Vice President Quality Assurance

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$/yr - $/yr

About the Company

For an Executive, Retained Search, a privately held, commercial-stage medical device company is seeking a Vice President of Device Quality Assurance to lead and evolve its Quality function during a period of operational growth and product expansion.

About the Role

This is a senior, hands‑on leadership role responsible for setting Quality strategy while remaining closely engaged with day‑to‑day execution. The role partners deeply with Operations, R&D, and Regulatory Affairs to ensure sustained compliance, product quality, and audit readiness across a portfolio of FDA‑cleared, sterile medical devices. The position is primarily onsite and requires strong collaboration with manufacturing and development teams.

Responsibilities

• Provide executive leadership for the Device Quality organization, including QA and QC teams
• Own and continuously improve the Quality Management System in compliance with 21 CFR 820 and ISO 13485
• Drive a culture of quality, accountability, and inspection readiness across the organization
• Partner cross‑functionally with Operations, R&D, Regulatory, and Commercial teams
• Lead Quality support for:
• New product development and line extensions
• Commercial manufacturing and product release
• Supplier qualification, oversight, and audits
• Serve as senior Quality representative during:
• FDA inspections
• ISO surveillance and recertification audits
• Customer complaints, investigations, and field actions
• Oversee and ensure effectiveness of:
• CAPA, nonconforming material, complaints, and risk management
• Design Quality and Design Controls
• Training systems and management review
• Environmental and microbiological monitoring
• Sterilization oversight (outsourced) and cleanroom operations

Qualifications

• 15+ years of Quality Assurance / Quality Engineering experience within medical devices or combination products
• 10+ years leading teams, including senior‑level direct reports
• Strong experience with sterile, disposable, single‑use medical devices
• Working knowledge of implantable devices strongly preferred
• Proven experience leading FDA and ISO audits
• Deep understanding of:
• ISO 13485
• FDA QSR / 21 CFR 820
• Biocompatibility and sterile product requirements

Education & Certifications

• Bachelor’s degree in Engineering, Science, Biomedical Engineering, or related field
• ISO 13485 Lead Auditor certification – required (active or commitment to renew)
• CQE or equivalent certification preferred
• Valid passport required (occasional travel)

Required Skills

• Strong data analysis and decision‑making capability (Excel, Minitab or equivalent)
• Executive‑level communication and presentation skills
• Comfortable operating in a fast‑moving, hands‑on environment
• Highly detail‑oriented with strong judgment and prioritisation skills

Preferred Skills

• Experience in a commercial, revenue‑generating medical devices environment
• High visibility and impact at the executive level
• Opportunity to shape and modernise Quality at a pivotal stage of the company’s evolution

To express interest:
Please apply directly or submit a confidential enquiry via Linked In.

Notes

Due to the confidential nature of this search, information has been deliberately withheld in order keep the company private, on an introductory call, the full JD and client name will be revealed.

• Seniority level Executive
• Employment type Full‑time
• Job function Quality Assurance
• Industries Medical Equipment Manufacturing

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