Director, Quality Assurance and Vigilance

The Director of Design Assurance & Site Quality is the senior quality leader for the Design Center, responsible for leading and developing the local Quality organization. This role owns and maintains the Design Center's QMS and serves as the Site Quality Management Representative, ensuring all products meet regulatory, compliance, safety, and performance requirements throughout their lifecycle. The Director provides leadership in Design Controls, Risk Management, DfX, Design Assurance, Design Transfer, Supplier Quality, Technical Documentation, and Audit/Inspection Readiness.

What You Will Do

Lead the site Quality organization, including Design Assurance, Quality Systems, and Compliance functions. Own and govern the full CAPA process for the Design Center, ensuring compliance with FDA QSR/QMSR, ISO 13485, ISO 14971, and corporate MedTech requirements. Lead Design Transfer activities from R&D to manufacturing sites, ensuring transfer packages are complete and compliant. Provide technical Quality leadership to complaint handling and product investigations, and support post-market performance.

Why It Might Be a Fit

This role requires over 10 years of previous experience and 5 years of experience in managing individuals, with deep expertise in Design Assurance, Design Transfer, DfX, and supplier management. The position offers a salary range of $185,000-$205,000 and is eligible for a bonus plan with a target of 16% of base salary. Benefits include a 401(k) plan with company contributions, paid vacation, holiday and personal days, and health benefits including medical, prescription drug, dental and vision coverage.

Requirements

• Over 10 year of previous experience and 5 years of experience in managing individuals.
• In depth knowledge of the regulatory environment for medical devices for globally distributed products: 21 CFR Parts 11 and 820, ISO 13485, ISO 9001, ISO 14971, Quality systems expert with knowledge of QSR, ISO, MDSAP, eu- MDR and other relevant regulatory requirements.
• Ability to develop and manage Quality Systems in compliance with all applicable regulatory bodies.
• The ability to effectively communicate with a broad spectrum of people having varying backgrounds, education, and experience.
• Demonstrated experience with FDA inspections and Notified Body audits required.
• Strong, practical, and pragmatic knowledge of both US and global Quality system requirements.
• Must have the ability to act as a change agent and drive/influence change as well as effectively lead and motivate team members to achieve goals.
• Strong leadership skills, demonstrated success in managing teams and ability to influence at senior level
• Excellent interpersonal skills with strong written and oral communications.
• Deep expertise in Design Assurance, Design Transfer, DfX, and supplier management.
• Strategic thinker with hands-on, analytical and pragmatic problem-solving skills.
• The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Medical coverage
• Prescription drug coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability coverage
• Wellness program
• Bonus plan with a target of 16% of the base salary