Customer Complaint Clerk Job Description Sample
Sr. Manager, Complaint Management
Sr. Manager, Complaint Management Ascensia Diabetes Care16 reviews-Tarrytown, NY Job Summary Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes. POSITION PURPOSE:Ascensia Diabetes Care has an opportunity within our Quality organization to manage and lead the Quality Complaint Management group, which includes complaint evaluation, failure analysis, customer product support, pre-launch product training, product quality and safety processes, and worldwide metrics analysis. This position will continuously improve existing processes and introduce new approaches and new technologies. A primary focus is to resolve issues which are highly complex and require very knowledgeable and sophisticated statistical and scientific approaches for effective resolution. This position demands the ability to work effectively within technical groups involving many different disciplines. MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
Manage ongoing technical support including investigation of customer complaints, returned goods testing and product problems.
Report product performance problems and product use trends.
Resolve product problems, provide timely feedback of resolution to customers, and ensure that appropriate corrective actions are implemented to address the root cause.
Work cross-functionally with Quality, Regulatory Affairs, Product Supply, Medical, Legal, Global Strategy, and Customer Service to analyze and resolve complaints.
Collect, analyze and monitor world-wide quality metrics for system improvements.
Develop short and long-term budget plans.
Work directly with the quality and service organizations globally to provide compliance training for complaint management and provide pre-launch training as needed.
Coordinate the execution of Stop Shipments when required.
Coordinate the Product Quality and Safety Process, including Issue Analysis and Health Risk Assessments. QUALIFICATIONS:
Graduate Degree in one of the life sciences or an engineering discipline, or equivalent in experience and training.
Ten (10) years of experience in Quality Assurance or a related field. At least five (5) years of experience in the management of a scientific discipline.
Must have familiarity with Quality System requirements in relation to compliance with the international medical device regulations identified in GSOP99-01, Diabetes Care Quality System Manual.
Excellent analytical skills and judgment.
Good understanding of statistical techniques.
Broad understanding of Good Laboratory and Good Manufacturing Practices, appropriate Diabetes Care policies, and various government regulations.
Strong organization, communication, leadership, and management skills to direct diverse, multi-disciplinary functions, prepare and manage budgets, and select, train, and motivate a qualified staff.
Ability to interface with people from different cultures, with varying levels of proficiency in a common language. YOUR APPLICATION:Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice. TO ALL RECRUITMENT AGENCIES:Ascensia does not accept unsolicited third party resumes. Ascensia is an Equal Opportunity Employer. IND123 Job Type: Full-time
Clinical Risk Specialist - RN - Complaint Handling
The Clinical Risk Specialist, RN - Complaint Handling position is located at Bard Medical Division in Covington, Georgia. The Clinical Risk Specialist will perform MDR/adverse event reporting, evaluate clinical use of product, analyze data to reduce occurrence/risk, analyze adverse events/complaint trends, and respond to regulatory inquiries. This position will ensure that all product complaints are documented, investigated, and reported in compliance to applicable Quality Systems regulations, ISO requirements, FDA regulations, and Corporate, Division, and International policies and procedures
Determine whether a product malfunction or serious injury report needs to be filed with the FDA. Determine whether a 30 Day or 5 Day MDR report is required. Write and/or approve MDRs submitted.
FDA-MDR contact for responding to FDA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD.
MHRA-MDR contact for responding to MHRA inquiries. Investigates, documents, and files adverse event reports (both domestic and international) for products marketed by BMD. Approve decision trees for vigilance reports/international competent authority.
Review and approve all adverse events decision trees in Trackwise (Domestic and International). Approve vigilance/international competent authority report to authorities.
Generate weekly MDR and Supplemental Reports.
Assess clinical risk of reported complaints using risk management tools (DFMEA), medical literature, or consultations with medical professionals.
May perform complaint and quality investigations related to manufacturing, design or clinical use issues. Review and approve investigations performed by the manufacturing site or OEM Supplier. Ensure consistency and attention to detail in performing and documenting complaint investigations.
Assist with Health Hazard Evaluations as needed for SPA and R002s
Analyze complaints and adverse events and communicate issues and resolutions to management.
Receive complaints and follow-up to collect relevant information from the user.
Make clinical severity and risk assessments, classify and assign FDA defect code. Where appropriate, arrange for HHE by a medical professional.
Monitor user related complaint trends. Coordinate customer in-servicing and follow-up with Sales Force and Clinical Educators.
Other duties as assigned. •
Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
Understands Fundamentals of Engineering Principles.
Ability to effectively manage time.
Ability to handle multiple task assignments.
Ability to translate quality requirements into product specifications.
Ability to interpret Regulations, Corporate, Division and Department Procedures.
Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency. Ability to interface with regulatory bodies to present technical information.
Comprehensive knowledge of quality systems and relationship to business.
Bachelor’s degree required. Nursing degree combined with two years of clinical experience preferred. (Urological specialties/women’s continence/pelvic floor surgical procedures/implantable preferred).
Preferred four (Level I) years of experience with FDA regulated industry including three years in complaint handling, MDR/adverse event reporting, and performing complaint investigations preferred.
Experience with complaint handling software (Trackwise or equivalent), Access Databases, and Excel (Pivot Tables and Charts). While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is frequently required to use hands to finger, handle or feel. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to fifteen pounds. Employee is required to meet with other personnel in other areas of the building. Specific vision abilities required by this job include close vision. This position works in a normal office environment. The noise level in the work environment is quiet to moderate. This position also has exposure to laboratoryenvironment, which mayrequire handling of all types of chemicals including those that present health, flammability, and reactivity hazards. Must be trained in blood-borne pathogens and handling bio-hazards materials. Industry Standard/Category: Clinical Risk Specialist/Healthcare ID: 2017-10978 Career Level: experienced Relocation: No External Company Name: C.R. Bard, Inc. External Company URL: www.crbard.com C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare. We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer. Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.
See attached Job Desription We welcome you to join Philips Volcano as an
Complaint Specialist in our Rancho Cordova, CA location
Your Key responsibilities include:
The Complaints Specialist (CS) performs investigations on Philips Volcano returned product to address complaints and/or allegations of customer dissatisfaction.
You will perform product analysis within the Failure Analysis Lab following good laboratory practices and Philips Volcano established procedures.
You will utilize a variety of test equipment, tools and devices in the execution of product analysis.
Notifies management and other required functions of investigation findings that are potential safety concerns.
Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally
Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.
Initiate complaint in process and applicable tool.
Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
Communicate with customers, call center reps and FSEs to gather more data on complaints as needed
Confirm complaint condition and determine corrective action (including CAPA as needed)
Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed
Assess if the Risk assessment is covering the hazard in the complaint
Complete all needed records in a timely and accurate manner
Requirements you bring to the team:
Bachelor’s Biomedical Engineering or other Engineering or Science discipline + 1+ years of related experience in complaints processing and/or investigation in the Medical Device, Pharmaceutical or regulated industry.
Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
Local post market surveillance regulation (21CFR, MDD93/42/EEC, other applicable market regulations)
Previous experience in Medical device and or applicable Consumer product
Product Knowledge is preferred
You are a part of In today’s challenging and changing healthcare environment, clinicians need every image to contribute to a confident diagnosis and every moment to matter in the clinical workflow.
In return, we offer you We offer you the opportunity to grow within the organization and Philips – working cross functionally with R & D, on various projects and initiatives to drive our products to our customers and be a part of saving people’s lives every day. Why should you join Philips? Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/Philips_Chronic_Disease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html . Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status. As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance
Sr Quality Assurance Scientist - Complaint Handling
Danaher Company Description Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Description The Senior Quality Assurance Scientist on the Post Market team will participate in complaint handling activities for the purpose of ensuring compliance with US and international regulatory compliance and medical device reporting requirements, as well as improving the customer experience.
* Receive and process complaints escalated from internal and external customers related to products manufactured and or distributed and serviced by the company in a manner consistent with all laws and regulations for medical devices.
Generate and analyze customer feedback (CF) data to improve product reliability and performance for our customers.
Assess complaint information for determination of adverse event reporting and/or vigilance reporting.
Possess understanding of risk management concepts and is capable of assessing product risks across unit of work.
Identify critical product issues and escalate through the quality system for Field Action, Corrective and Preventive Action (CAPA), Supplier Corrective Action, and/or Stop Shipment activities.
Independently and collaboratively evaluate information, reports, and data and provide recommendations for process improvements.
Oversight of critical Post Market projects and routinely share project goals, status, requirements, and deliverables to upper management. Communicate, work cross-functionally and consult frequently with Manufacturing, Operations, Engineering, Service/Support, Sales, Research and Development, Quality, Regulatory and Marketing. Ensure completion of key deliverables.
Bachelor’s degree with 5 years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
Master’s degree with 3 years in Science or Engineering discipline, or relevant years of Quality/Regulatory Affairs experience
Medical Technologist /Clinical Laboratory background preferred Experience desired:
Knowledge of domestic and international quality systems and other standards such as FDA, QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations.
Ability to drive results, foster teamwork, handle pressure, and provide feedback
Experience leading cross functional teams 1.
Danaher Corporation Overview Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Organization: Beckman Coulter - Diagnostics
Quality and Regulatory Affairs
Primary Location: North America-North America-United States-FL-Miami
Req ID: BEC008663
Quality Complaint Technician
Job Title: Quality Complaint Technician
Duration: 12+ months
Location: Alameda, CA
W2 hourly rate
· The Technician will perform routine testing of medical devices in order to replicate customer complaints and if applicable identify the root cause of the complaint.
· The technician will need to document investigations accurately, and maintain organized files to keep track of investigated product. Job duties will also include unpacking customer returns, and receiving product into the Complaint Handling Database.
· We are looking for “doers” not candidates who have Master’s degrees as they may be overqualified. Manager would Strongly Prefer Candidates who have experience ~ testing medical devices in a medical device or biotech company.
· Would prefer QA/QC or manufacturing types. Previous experience working in a regulated environment and following SOP’s is a plus. Familiarity with printed circuit boards and the ability to read schematics is also a plus.
· Experience working in manufacturing or high volume areas, ability to work at a fast pace while maintaining quality work is also a plus. In addition, ability to perform routine / repetitive work as the lab is very standardized and you must follow procedures.
· Candidates without previous industry experience will also be considered, especially if they have previous work history that shows good organizational, documentation, analytical, and/ or technical skills or they have an Associates/ Bachelor’s degree.
QA Complaint Admin
PDS TECH INC. is seeking QA Complaint Admin position located in Salt Lake City, UT
The QA Complaint Admin will be responsible for assisting with processing of complaint records through Master Control.
Must be people friendly and able to take direction. Must be computer literate and able to learn new software quickly.
Must be able to think logically and make decisions, but also be willing to ask questions when unclear on how to process a complaint record.
Analytical experience desired. Good computer experience (Word, Excel, Windows) is a must.
• Reviewing complaints for report-ability to regulatory bodies • Assist in submission of MDR's to FDA for reportable events
• Self-starter and able to manage a variety of tasks simultaneously with minimal day-to-day work instruction • Excellent analytical and communication skills • The ability to work well under pressure • Ability to effectively communicate via email/telephone • Strong computer skills including Word, PowerPoint and Excel • Able to succeed in highly regulated compliance oriented environment while still providing service excellence • Experience as an Administrative Assistant a plus • Experience in a Customer Call Center Environment a plus All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
Complaint & Appeal Analyst
Req ID: 45491BR POSITION SUMMARY Responsible for managing to resolution complaint/appeal scenarios for all products, which may contain multiple issues and, may require coordination of responses from multiple business units. Ensure timely, customer focused response to complaints/appeals. Identify trends and emerging issues and report and recommend solutions. Fundamental Components: Process Medicare Member Appeals within the timeframe outlined by Medicare. Ability to adhere to the strict resolution timeframes established by the regulatory agencies. Collaboration with clinical constituents during the research phase of cases in inventory. Ability to handle a high volume of work in a fast pace environment. Maintain department production standards. Ability to understand and adhere to legislative and regulatory standards that impact the company STARS metrics. BACKGROUND/EXPERIENCE desired: 1-2 years experience that includes both HMO and Traditional claim platforms, products, and benefits; patient management; product or contract drafting; compliance and regulatory analysis; special investigations; provider relations; customer service or audit experience. Experience in research and analysis of claim processing a plus. Experience in reading or researching benefit language in SPDs or EDUCATION The minimum level of education desired for candidates in this position is a Bachelor's degree or equivalent experience. FUNCTIONAL EXPERIENCES Functional
Products-Medical/Individual Medicare Advantage Plan/4+ Years Functional
Medical Management/Medical Management
Clinical coverage and policies/4+ Years Functional
Medical Management/Medical Management
Complaints, Grievance & Appeals/4+ Years Functional
Medical Management/Medical Management
Home health care/4+ Years Functional
Medical Management/Medical Management
Legislative and regulatory compliance/4+ Years TECHNOLOGY EXPERIENCES Technical
Computer Operations/System and Console Operations/4+ Years/End User Technical
Remote Access/Broadband VPN/4+ Years/End User Technical
Hardware/PCs/4+ Years/End User Technical
Hardware/Mainframe/4+ Years/End User REQUIRED SKILLS General Business/Communicating for Impact/ADVANCED Leadership/Collaborating for Results/ADVANCED Service/Providing Solutions to Constituent Needs/FOUNDATION DESIRED SKILLS General Business/Maximizing Work Practices/ADVANCED Leadership/Creating Accountability/ADVANCED Leadership/Driving a Culture of Compliance/ADVANCED ADDITIONAL JOB INFORMATION The team is a team collaborates on a regular basis. This team has many with very high skill set and they are very enthused with supporting any addition to staff.
This team has a very low turn over rate. The team is very unique and perform high level review of Member appeals. This is a very rewarding position as it allows all to help our Medicare membership.
The team is very member focused. Aetna is about more than just doing a job. This is our opportunity to re-shape healthcare for America and across the globe.
We are developing solutions to improve the quality and affordability of healthcare. What we do will benefit generations to come. We care about each other, our customers and our communities.
We are inspired to make a difference, and we are committed to integrity and excellence. Together we will empower people to live healthier lives. Aetna is an equal opportunity & affirmative action employer.
All qualified applicants will receive consideration for employment regardless of personal characteristics or status. We take affirmative action to recruit, select and develop women, people of color, veterans and individuals with disabilities. We are a company built on excellence.
We have a culture that values growth, achievement and diversity and a workplace where your voice can be heard. Benefit eligibility may vary by position. Click here to review the benefits associated with this position.
Aetna takes our candidate's data privacy seriously. At no time will any Aetna recruiter or employee request any financial or personal information (Social Security Number, Credit card information for direct deposit, etc.) from you via e-mail. Any requests for information will be discussed prior and will be conducted through a secure website provided by the recruiter.
Should you be asked for such information, please notify us immediately. Job Function: Risk Management
Clinician, Complaint Handling & Safety Surveillance
The Clinician, Product Safety and Performance is responsible for activities related to product safety surveillance and risk management, including review of data from clinical studies, literature reviews and spontaneous complaints for accuracy, completeness, regulatory reporting and potential safety issues. This individual reviews and prepares reports on aggregate data and provides recommendation for further escalation. Prepares Complaint Trend Analysis, product risk assessments including Health Hazard Evaluations, Clinical Evaluation Reports, risk management documents and FMEAs. Assist in benchmarking best practices with world class organizations, interface with notified bodies, and/or other regulators and provide input to establish metrics. Interacts with internal and external manufacturing entities as Safety Surveillance representative. Accountabilities
Provide guidance to Complaint Handling Specialists regarding investigation of product related events reported worldwide from patients, customers, sales reps and clinical studies/registries in order to assess product relationship to reported complaint. Contacts customers as needed.
Provide clinical guidance and validate correct coding and regulatory reporting of complaint files by reviewing daily complaint reports and published literature.
Maintain and improve established coding guidelines to ensure consistency and accuracy with coding and reporting events + Assess customer complaints for potential regulatory reporting, based on product specific criteria + Prepares Clinical Conclusions for reportable complaints and provides final review of MDR/MDV reports + Verify that assessments of regulatory reporting requirements are accurate and in accordance with regulatory guidelines and product labeling + Compose clinical conclusion to be included in the reports to competent authorities around the world
Evaluate FAL findings for appropriateness and any significant issues
Review of technical investigations and completeness of conclusions for returned product analysis for inclusion in Medical Device Reports. Evaluate and provide feedback; evaluate need for escalation.
Review of weekly complaint report to identify any significant issues that need to be escalated or expedited + Develop malfunction code list and regulatory reporting tables is support of product launch activities (preparing surveillance system to capture data) + Monitor customer complaint data for product quality trends
Review of monthly surveillance data to identify any significant triggers and provide an analysis of the triggered events to identify any safety concerns + Participate in monthly trending board meeting and provide input on actions taken for identified signals + Complete Trend Analysis and make recommendations for further escalation when appropriate + Complete Distributed Product Risk Assessment Health Assessment portion and participate in Quality Leadership Team discussions by providing surveillance data analysis and severity assessment per risk management documentation
Lead monthly risk management/complaint meetings with manufacturing sites
Review monthly safety surveillance data with both Cordis and OEM manufacturing sites + Represent Quality Clinical interests in multi-disciplinary teams during product development + Perform clinical reviews and provide input of clinically related product risk issues during the development of the clinical portion of risk management documents such as FMEA’s, Risk Management Plan, Risk Management Report and Clinical Evaluation Report in support of new product development and regulatory requirements + Perform clinical reviews and provide input to Health Hazard Evaluations for known quality issues under investigation.
Evaluate and review of non-Clinical contributions to risk management documents such as FMEAs, Risk Management Plans, Risk Management Reports and Distributed Product Risk Assessments for conformance to procedure, completeness, content and accuracy + Ensure that safety surveillance operations activities supporting product release are efficient, effective and meet target timeframes from both a compliance and business perspective + Act as Medical Safety representative for clinical changes and non-regulatory change assessments to Instructions for Use
Provide clinical complaint review as requested from regulatory bodies for individual complaints, annual reports or for certificate renewal + Coordinate, prepare, or review complaint data for regulatory submissions for domestic or international projects and audits.
Provide education and training to employees worldwide about products, best practice to report complaints and return complaint products + Participate in site or global projects and improvement efforts, as needed + Participate in internal or external audits
Provides education and training of Cordis employees about clinical applications of Cordis products Qualifications
Must possess a Registered Nurse (RN) degree/ license + A minimum of a Bachelor's degree in Nursing or a scientific discipline is preferred + A minimum of 5 years of Interventional Radiology/Cardiology or ICU experience is preferred + Experience using vascular interventional devices is preferred + Regulatory Affairs/ Quality Assurance and/or complaint handling experience in the Pharmaceutical or Medical Device industry is preferred + Experience with health hazard evaluations is preferred + Experience interacting with the FDA is preferred + Risk Management experience is preferred Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Product Complaint Analyst
- Looking for product complaint handling (this position deals with diabetes glucose meters) – this is in the reg affairs space not engineering space so CAPA people are not a fit
- MDR complaint processing experience is HUGE – but not required
- Complaint investigations - Filing submissions and determining the report-ability of the complaints on the medical devices and whether or not the common issues that are occurring are reportable to the FDA
- May reach out to physicians to get info to help the investigation.
- (will take complaint handling non-medical device if it’s FDA regulated – i.e. pharma)
- Will probably not hire off the phone but will consider non-local candidates – if they can make it to an in-person meeting for the second interview
Corresponds with customers regarding the results of inquiries and analysis of products Uses discretion in escalating unusual product performance issues, collaborates with engineering, resolves customer complaints. Participates in product improvement teams, field failure analysis and other analytical teams responsible for the improvement of products and regulatory issues. This position requires a very high degree of technical competence and communicative ability in order to receive, evaluate, investigate and respond to customers' questions and complaints.
Interfaces with all levels of health care professionals ( doctors, nurses, biomedical technicians and purchasing agents, materials managers and risk managers) to document, investigate, and correct field-related problems.
Communicates customer concerns and complaints to individuals who manage databases and analyze data to identify trends, needs for product and service enhancements and communicate the findings with relevant individuals such as R & D engineers, business unit managers, and other personnel to communicate the findings.
Performs product complaint documentation, investigation, customer response, and consulting activities on products and authors correspondence to customers addressing complaint investigations.
Serves as a liaison between other business units for quality and technical concerns as needed. Knowledge of Medical Terminology. Five - seven years of customer support experience preferred. Strong PC/Data Entry Skills required. A high degree of interpersonal relations skills. Strong verbal and written communication skills. PROBLEM SOLVING: Must be able to work under pressure and stress common to office environments. Must be able to maintain a high degree of accuracy and analytical thinking. Must be able to deal effectively with problems and customers on the telephone.
Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.
At The Fountain Group, we know that searching for a new career can be stressful, which is why we take time to understand your skills and personal goals. We understand the importance of job flexibility and professional growth, and offer top-notch positions with leading employers. In fact, the majority of our clients are well known Fortune 100-500 companies. We also offer a variety of benefits to our associates to ensure their overall happiness.
In addition to assisting with your job search, we will help you through every step of the process offering online tutorials and additional resources to enhance your industry knowledge and skills. As your employment agent, we are dedicated to providing career counseling and job advice, knowing precisely what established companies want.
At The Fountain Group, we treat you like family, regardless of your proximity to our office. We are dedicated to providing you with an exciting, challenging and highly rewarding place to work. Become a part of our team today and let us put your talents to work.
If you are interested in hearing more about the position please respond to this email with a copy of your resume in word form with the best contact info Please forward this email to any friends or colleagues
Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a
Complaint Specialist with our client, a leader in the medical device industry, located in Rochester, New York. Day shift! One year contract!
Complaint Specialist Primary responsibility is to support the global reporting obligations and the management of communication between manufacturer, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.
Provide understanding, leading analysis and management of information regarding medical device complaint events and/or adverse events, follow-up, case processing and assessment for post-marketing activities including: Receives, documents and evaluates complaint information As required, communicates with physician, physician’s staff and/or patient to obtain pertinent complaint information.
Evaluates and engages appropriate management for critical and/or unusual events. Liaises with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input into medical device event reports. Reviews complaint manufacturing investigation reports and provides comments in accordance with procedures.
Ensures complaints are processed in a timely manner Reviews and closes complaint files. Compiles case and process metrics. Performs and/or documents regulatory reportability decisions on complaints in accordance with applicable local laws regulations.
Communicates with local and international competent authorities, including generation and/or submission of medical device event reports as required by applicable local laws and regulations. Assists local affiliates with the preparation and submission of medical device complaints and or incident reports, when required. Coordinates and prepares responses to competent authority inquiry’s associated with medical device report submission (Serious Injury and/or Device Malfunction). Participate in preparation for Notified Body audits and or Competent Authority inspections.
When required, support root cause investigations and participates in CAPA (Corrective and Preventive Action) activities. Supports complaint handling trending activities. Generates complaint data reports for other departments, when requested. Generates periodic reports as requested per government agencies
Requirments: Bachelor‘s degree in scientific or business related discipline required. Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance Reporting regulations, GMPs for medical devices preferred.
Position requires strong written, oral and listening communication skills in order to interact with customer and other professionals. Must be able to generate and organize clear, concise responses when communicating with various levels of management. Superior organizational skills to be able to manage challenging deadlines.
Recognizes problems and suggests applicable solutions. Able to perform job function with minor supervision and make independent decisions, where appropriate. Proficient in the use of personal computers, including database management, trending and word processing.
Minimum of 2 years related work experience is required Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch.
Applicants must be legally permitted to work in the United States. Why Kelly? As a Kelly Services employee, you will have access to numerous perks, including: Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group-rate insurance options available immediately upon hire*
? At Kelly Services ® , we work with the best. Our clients include 95 of the Fortune 100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to access the best talent to drive their business forward. If you only make one career connection today, connect with Kelly.
® As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion.
Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
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