Senior Manager, Quality Assurance

About the role

Join a global operations and quality team dedicated to delivering life‑changing cardiovascular medical devices. As Senior Manager, Quality Assurance you will lead a team that ensures smooth, continuous operation of the site quality system, from in‑process inspections to final product release.

Key responsibilities

• Lead and develop supervisors and the assigned quality‑assurance team, creating a talent development plan aligned with departmental growth.
• Oversee process audits, final product release documentation, and compliance investigations for bioprosthetic heart valves and rings.
• Manage quality‑assurance projects (CAPA), ensuring deliverables meet schedule, scope, and quality objectives.
• Identify risks, develop mitigation strategies, and resolve issues in collaboration with manufacturing, supply chain, and engineering.
• Coordinate cross‑functional inspection of in‑process and finished goods, assemblies, and components.
• Negotiate continuous‑improvement solutions and lead implementation of changes to drive operational excellence.

Required profile

• Bachelor’s degree in a related field.
• Minimum five years of experience in the medical‑device industry, including inspections/audits by external regulatory agencies for Class II/III devices.
• Proven people‑management track record.
• Strong decision‑making ability in a fast‑paced, patient‑first environment.

Required skills

• Regulatory inspection and audit expertise for Class II/III medical devices.
• CAPA (Corrective and Preventive Action) project management.
• In‑depth knowledge of applicable quality regulations (e.g., ISO 13485).
• Ability to develop and integrate performance metrics into quality operations.
• Risk identification and mitigation experience.