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Are you passionate about quality assurance and regulatory compliance in the medical device industry? Terumo Aortic is seeking a Standards Compliance Quality Specialist to join our Quality Systems team.
Key Responsibilities
1. Monitor and evaluate new and revised standards/regulations for impact on products and QMS processes.
2. Review updates to regulations and standards to ensure ongoing compliance of products and systems.
3. Maintain compliance throughout the product lifecycle—from design and development to manufacturing and post-market surveillance.
4. Identify gaps in regulations/standards and coordinate actions with relevant departments.
5. Facilitate closure of compliance actions and monitor status via trending.
6. Present status updates during meetings and highlight risks to management.
7. Ensure all processes and procedures meet regulatory standards (EU MDR, ISO, CFR Part /QMSR, Japan MHLW Ordinance, and other country-specific regulations).
8. Collaborate with R&D, manufacturing, and regulatory teams to integrate compliance into product design and development.
9. Provide training and guidance on regulations/standards and compliance best practices.
10. Conduct internal audits and support external audits as a subject matter expert FDA inspections, Notified Body audits, Customer audits).
11. Generate and maintain trending data for the Standards Management process and publish as part of QMS governance forums.
12. Update QMS documentation with respect to key changes for standards, working closely with cross-functional SMEs.
What We’re Looking For
13. Degree in Science/Engineering or equivalent background.
14. Class III medical device knowledge (desirable).
15. In-depth knowledge of medical device regulations and standards (FDA, ISO, EU MDR).
16. Experience with QMS tools and document control systems.
17. Strong analytical, problem-solving, and communication skills.
18. Certification such as CQE, CQA, or Lead Auditor (ISO ) is highly desirable.
19. Ability to work independently and influence change with objective information and well-structured communications.
20. Competence in IT technology (Microsoft Office and QA systems).