Director of Quality Assurance – Medical Device

Retained Search

Must be within a commutable distance of the Greater Boston area or willing to relocate.

Our client is at the forefront of the healthcare industry, providing innovative and comprehensive solutions for hospitals. Their focus is developing and commercializing medical devices, software, and services, improving healthcare delivery, and enhancing patient outcomes.

Position:  The Director of Quality Assurance will be instrumental in defining Quality Management goals and ensuring alignment with my client’s other relevant business targets. In this role, you will be the point of contact with notified bodies while leading a team of Quality Professionals.  

Responsibilities:

• Maintain compliance and continuously improve QMS for ISO 9001, ISO 13485, MDD 93/42EEC, MDR 2017/745, and 21 CFR Part 820 and further regulatory requirements that apply to the product portfolio.
• Serve as the focal point of contact with the Notified Bodies, including delegate PRRC.
• Serve as the delegate point of contact for FDA, TÜV, regulatory, and third-party audits and inspections and/or preparation as necessary.
• Responsible for supporting Product Quality, Complaint Review, and QMS Boards.
• Analyzes and reviews quality management goals and breaks down corresponding goals for the relevant product quality targets.
• Defines Quality Management goals and ensures alignment with other relevant business goals.
• Manages the Post-Market Surveillance Team and the requirements of 21CFR 803, 806, and 820.198, as well as other country regulations as required.
• Monitors and reviews CAPA implementation and closures.
• Participates in internal audits as part of the yearly audit program.
• Assures effective Quality System compliance within each CFT, Product Steering Board, and Product Quality Board.
• Responsible for the lifecycle (hiring, developing, retaining) of direct reports. Coach and guide individual contributor staff. Manages the performance of the team.

Requirements:

• Bachelor’s Degree in a scientific discipline, life sciences, biomedical or other engineering science – Master’s or a PhD (desired).
• Minimum of 10 years experience in a Quality Leadership role in the medical or device industry with at least 5 years in a management role.
• Ability to develop, implement, and manage an integrated QMS; to lead multi-level and multi-discipline work teams to develop, implement, and manage processes/business systems.
• Quality and Environmental (knowledge of current ISO 9001, ISO 13485, IEC 62304, ISO 14001).
• CMDR SOR/98-282, MDD 93/42/EEC and MDR 2017/745, 21 CFR Part 820, where applicable.
• A formal Six Sigma qualification is preferred.
• Ability to develop and manage an integrated QMS; to lead multi-level and multi-discipline work teams to develop, implement, and manage processes/business systems.
• Preferred experience managing both quality and regulatory.
• Strong interpersonal and communication skills and the ability to persuade and influence others at all levels within the company.
• Proven track record in applicable disciplines of ISO 9001, ISO 13485, US FDA and MDD compliant Quality Management, and ISO 14001 Environmental Management systems and demonstrated success in developing a proactive organization in a compliant environment.
• Sound people management and change management experience.

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