Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products.
We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.
At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.
Join us and help shape wherever we go next!
Advancing healthcare with heart
Job Summary
The Senior Manager, Medical Device Product Complaints is responsible for managing medical device complaints in accordance with applicable global regulations (21 CFR Part 820, ISO 13485:2016, EU MDR etc. S/he will be responsible for directing personnel and maintaining all activities associated with customer complaints. S/he will work closely with the Customer Service and Field Service groups to process all customer service issues and to identify customer complaints, as required by FDA, Canadian, European and International regulations related to medical device manufacturers and will maintain all complaint and complaint investigation files according to Terumo quality system requirements. This person will work with stakeholder departments such as Engineering, Operations, Clinical, Medical Affairs and Regulatory Affairs on Post Market Surveillance strategy and execution.
Job Details/Responsibilities1. Serve as a member of the TMC Quality Management Leadership Team.
2. Oversee medical device complaint processing in compliance with applicable regulations and standards such as FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, EU Medical Device Regulation, etc.
3. Drive engagement to ensure personnel have clear expectations, appropriate tools and information, an opportunity to share, grow and develop and are recognized for their contributions.
4. Serve as a subject matter expert for complex regulatory and compliance issues, including regulatory and procedural interpretations, processes such as risk assessment, investigation, medical device reporting and tracking/trending analysis during audits, inspections and assessments by regulatory agencies and corporate bodies.
5. Manage the timely in-flow of customer complaints, the assignment of investigation responsibilities and expedient processing and closure of complaints to meet corporate QPI metrics. Ensure complaints are properly evaluated for MDR and Vigilance Reportings. If required, ensure reporting takes place in a timely manner. 6. Identify process improvement opportunities to enhance surveillance and increase efficiency.
6. Work closely with manufacturing sites and engineering to ensure thorough and accurate investigations and drive the initiation of product complaint related CAPAs when appropriate
7. Work closely with new product introduction teams to prepare tools, processes, resources and personnel for complaint management on new product launches.
8. Assisting RA/QA management and engineering personnel with the identification of quality, reliability and compliance issues from the review and analysis of customer complaint information and trending data and ensuring that all Corrective & Preventive Actions (CAPA) have been identified and assigned according to documented compliance systems.
9. Develop and maintain data mining tools to monitor product complaint trends. Define control and/or action limits to detect emerging field issues. Based on surveillance findings, collaborate with technical groups to identify product improvement opportunities; assist in establishing engineering priorities.
10. Manage preparation and reporting of quality data for purposes of Post Market Surveillance and as the primary input into the Management Review process.12. Direct involvement and interface with internal and external auditors, including FDA and Notified Bodies, relating to all activities, reports and files associated with the complaint / MDR and CAPA system processes.
11. Establish and maintain complete MDR / Vigilance files and records for all reportable customer complaints to the applicable regulatory authorities. Act as the primary adverse event designee for Terumo Medical Corporation. Responsible for adverse events reporting for designated Terumo affiliates.
12. Coordinate, execute and manage the mobilization of the execution team for global medical device recalls managed by Terumo Medical Corporation..
13. Keep abreast of industry and regulatory trends and changes.
14. Performs other job-related duties as assigned.
Strong drive to achieve results and meet commitments. Demonstrated success at consistently achieving business and quality objectives.
Qualifications/ Background Experiences Bachelors degree in science, math or related technical field preferred. Minimum 10 years of experience in medical devices or similar regulated industry, at least 5 years in a supervisory role. Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook
Benefits and Compensation
We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. Pay range for this position is $129,000 - $193,600
It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.