Vice President, Quality

Vice President, Quality

About the Company

Develops Class II/III medical devices with a focus on quality and regulatory compliance

Industry
Medical Devices

Type
Privately Held

About the Role

The Company is seeking a Vice President of Quality to provide executive leadership for its quality organization and quality management system. The role will set and execute quality strategy while overseeing quality systems, design assurance, manufacturing, suppliers, and post-market activities. The successful candidate will guide quality and compliance throughout product development, commercialization, and manufacturing scale-up, and lead programs for risk management, corrective and preventive actions, complaints, audits, and inspection readiness. They will partner with cross-functional leaders, drive metrics and continuous improvement, and advise executive leadership on quality, compliance, operational risk, and product performance. Candidates should hold a bachelor’s degree in engineering, life sciences, or a related technical field; an advanced degree is preferred. At least 15 years of progressive medical-device quality experience, including eight or more years in leadership, is required, along with experience leading multidisciplinary quality teams in Class II or Class III device environments. Deep expertise in quality systems, design controls, risk management, supplier and manufacturing quality, and process validation is essential. Candidates should have led regulatory inspections and audits and be effective partners to senior leaders. Experience with implantable devices and relevant professional or continuous-improvement certifications is preferred.

Functions

• Operations