Vice President of Quality Assurance

Vice President of Quality Assurance

About the Company

Growing cardiovascular medical device company with commercial products and clinical-stage technologies.

Industry
Medical Devices

Type
Privately Held, VC-backed

About the Role

The Company is in search of a Vice President of Quality Assurance to spearhead the quality strategy for its commercial products and clinical-stage technologies. The successful candidate will be responsible for the oversight of the QMS, quality engineering, clinical quality, supplier quality, compliance, and global quality initiatives. This executive leadership role demands a professional with a minimum of 15 years' medical device quality experience, including a background in senior leadership, and a strong focus on Class II/III devices, particularly in the cardiovascular or implantable product space. The VP of Quality Assurance will be a key partner to the regulatory affairs, clinical affairs, R&D, and operations teams, and must have a proven track record in building and leading high-performing quality organizations. Applicants for the VP of Quality Assurance position at the company should possess a deep understanding of FDA regulations, ISO 13485, ISO 14971, design controls, CAPA, and risk management. Experience in supporting clinical studies and regulatory inspections is essential. The role offers the opportunity to work with an innovative cardiovascular pipeline and requires a leader who can ensure the highest quality standards are met across all products, both commercial and in the clinical trial phase. The ideal candidate will have a strong background in quality assurance within the medical device industry, with a focus on driving continuous improvement and maintaining a culture of quality and compliance.

Functions

• Operations