Position is responsible for ensuring that management is effectively informed of systems and procedures that are necessary to establish compliance with applicable US Federal Quality Systems Regulations and applicable international standards / regulations (such as ISO, CMDR, PAL, the Medical Device Directive
93/42/EEC, etc.). Position oversees and directs Terumo Medical Corporation Quality Management Systems activities and, upon request, provides quality systems assistance for other Terumo facilities. This position is responsible for properly completing all assigned Compliance activities and for ensuring that management is effectively informed of requirements that are necessary to establish compliance with applicable sections of the US Code of
Federal Regulations and international standards / regulations (such as ISO standards, CMDR, PAL, the Medical Device Directive 93/42/EEC, etc.). Failure to do so can result in remedial action ranging from training of associates to market recall, litigation or regulatory action by the FDA to address the situation. This position is also responsible for making decisions that affect the operation of
the entire company with regards to addressing issues with customers, Notified Body, the FDA, or other government agencies. This position directs changes in company policy to ensure product safety and effectiveness, ethical behavior and compliance with applicable requirements.
1. Maintain and follow proper quality system procedures and maintain up-to-date knowledge of applicable national / international QS/GMP regulations, standards, guidelines and regulated industry trends 2. Investigate, audit, analyze, propose improvements and direct the assigned Quality Management System activities including Design reviews, Adverse Event reporting, root-cause investigation and resolution 3. Establish, organize, monitor and approve the annual Quality System improvement projects and Internal Audit Program in coordination with the Quality Managers 4. Support activities related to the Products Liability policy including annual renewal, notification of insurance claims / legal action, investigation of related events, when necessary 5. Interact with
customers to address technical inquiries, conduct complaint investigations & understand changing demands within the health care provider / end-user environment 6. Improve procedures and processes to enhance corporate integrity, encourage ethical behavior, optimize quality, cycle-time efficiency, productivity,
manufacturing cost and Terumo’s business performance 7. Provide Quality Systems assistance for Terumo facilities including Clinical & Quality System training and development of Terumo associates on a global basis, including TMC and affiliates 8. Conduct internal audits, inspections, validations and review contracts prior to approval, as needed 9. Conduct and administrate new hire training and ongoing GMP training for the corporation 10. Assist to direct the program of activities during FDA inspections, Notified Body and other 3rd-party Quality System audits 11. Participate in project
performance team meetings on behalf of the job unit in order to provide ideas, methods or processes for unit/company performance improvement 12. Assist management of other regulated processes including occupational safety, environmental protection, labor laws, transportation regulations, Sales/Marketing activities. 13. Performs other job-related duties as assigned. Internal Contacts: President/CEO, Vice Presidents, QA/RA, CIO, Legal/Compliance and Management staff and associates across the organization. External Contacts: Customers, Industry peers, FDA, Health Canada and other regulatory agencies (TPA, MLHW, MDA, BfARM, etc.), Notified Body Representatives
• Position requires a 4-year degree in a technical/science area; an advanced degree is preferred. • 8 to 10 years in a regulated industry with 5 or more years in a management position is also required. • Significant experience with quality systems, engineering design controls, injection molding, production, sterilization, bio-safety testing of materials, controlled environments, and clinical use of medical devices is also required.
• Incumbent must possess strong interpersonal verbal and written communication skills. • Must be able to address regulatory questions from FDA investigators / Notified Body auditors by successfully communicating the company’s methods of compliance with the applicable regulations and standards. • Incumbent must maintain up-to-date knowledge of all applicable regulations, guidelines and regulated industry trends. • Independent decision-making is expected for all routine business issues including interactions with the FDA, Notified Body, customers, etc. Must be able to assess the level of compliance in each area.