Head of Quality, Device and Combination Products

Role Summary

As the Head of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices and combination products. This role involves establishing cross-functional roles and serving as the primary quality representative for drug-device combination engagements. You will oversee the Global Quality Device organization, ensuring quality management across all stages from design to lifecycle activities. Your leadership will drive compliance with regulatory and quality standards while fostering continuous improvement, ultimately supporting the uninterrupted supply and compliant lifecycle management of devices and combination products.

Responsibilities

• Develop and implement quality business strategies for internal and external device/combination product programs.
• Lead the global quality team supporting design, development, manufacturing, and quality operations.
• Lead and support transfers, deviations, investigations, and CAPAs.
• Ensure execution of a robust, compliant QMS for end-to-end lifecycle management.
• Participate in Health Authority audits and management reviews.
• Ensure oversight of GxP activities and provide quality engineering guidance.
• Lead or support continuous improvement of the Device and Combination Product QMS.
• Represent Quality Operations on cross-functional initiatives and development programs.
• Support internal, external, CMO audits, certifications, and regulatory inspections.

Qualifications

• A minimum of 12 years of medical device quality, engineering, and packaging experience with at least 5 years in clinical quality operations and/or device quality.
• Comprehensive knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU Medical Device Regulation.
• Experience in engaging with regulatory authorities and notified bodies.
• Experience in people management (>5 years) and project management.
• Strong understanding of CMO-mediated Supply Chain activities.
• Experience working in international matrix environments.
• Expert knowledge of supplier management and relations, including negotiation skills.
• Experience with process development and validation.

Education

• BS in Chemical Engineering, Mechanical Engineering, or relevant field