Position Summary

We are seeking a strategic and hands-on Senior Director or Vice President of Quality to lead the quality assurance and quality systems functions at an innovative medical device company. The ideal candidate will bring deep expertise in quality leadership for devices that combine hardware, software, and embedded systems. This leader will be responsible for ensuring ongoing compliance with FDA, ISO 13485, and global regulatory requirements, while fostering a culture of quality throughout the organization.

Key Responsibilities

• Set and execute the quality vision and strategy aligned with company goals and regulatory requirements.
• Build, lead, and mentor a high-performing quality team, including QA, QMS, and Supplier Quality personnel.
• Serve as the voice of quality in executive discussions and cross-functional initiatives.
• Own and continuously improve the Quality Management System (QMS) in compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable regulations.
• Oversee document control, CAPA, internal audits, nonconformance, risk management, and supplier quality programs.
• Collaborate with R&D, Manufacturing, and Regulatory to ensure product design and manufacturing processes meet quality standards from development through post-market.
• Ensure robust design controls, verification and validation (V&V), and design history file (DHF) documentation for 510(k)-cleared devices.
• Lead preparation and execution of FDA inspections, Notified Body audits, and other regulatory assessments.
• Ensure timely resolution of audit findings and implementation of corrective/preventive actions.
• Develop and maintain supplier quality programs, including audits, incoming inspection, and performance monitoring.
• Partner with Operations and Contract Manufacturers to ensure consistent production of high-quality products.
• Define and monitor quality metrics to identify trends, risks, and opportunities for continuous improvement.
• Promote a proactive, risk-based approach to quality throughout the organization.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (Master’s preferred).
• 10–15+ years of progressive quality leadership experience in medical device companies.
• Direct experience with electromechanical devices, including software/firmware preferred.
• Deep knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and applicable IEC standards (e.g., IEC 60601, IEC 62304).
• Proven track record of leading FDA inspections, Notified Body audits, and post-market compliance programs.
• Strong understanding of design controls, V&V, risk management, and product lifecycle requirements.
• Exceptional leadership, communication, and cross-functional collaboration skills.

Preferred Qualifications

• Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certifications.
• Experience scaling quality systems in high-growth or early-stage environments.
• Familiarity with global regulatory environments (EU MDR, Health Canada, etc.).
• Experience working with contract manufacturers and external design/test partners.