Sr. Mgr Med Device Prod Complain

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/Responsibilities

1.    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
 

Job Responsibilities (continued)

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