VP, Quality Assurance

About the role

Growing cardiovascular medical device company seeking a VP of Quality Assurance to lead Quality strategy across commercial products and clinical-stage technologies.

Responsibilities

- Oversee the QMS, Quality Engineering, Clinical Quality, Supplier Quality, Compliance, and global quality initiatives. - Partner closely with Regulatory Affairs, Clinical Affairs, R&D, and Operations. - Support clinical studies and regulatory inspections. - Build and lead high-performing quality organizations.

Requirements

- 15+ years of medical device Quality experience, including senior leadership. - Experience with Class II/III devices, preferably cardiovascular or implantable products. - Strong expertise in FDA regulations, ISO 13485, ISO 14971, Design Controls, CAPA, and risk management. - Proven ability to build and lead high-performing quality organizations.

Qualifications

- Bachelor's degree in a related field. - Professional certifications such as CQA, CQE, or equivalent. - Leadership experience in a quality assurance role.

Skills

- Excellent communication and interpersonal skills. - Ability to work collaboratively with cross-functional teams. - Strong problem-solving and decision-making abilities.

Benefits

- Competitive compensation, bonus, and equity opportunity. - Hybrid work schedule. - Growing company with an innovative cardiovascular pipeline.

Pay

- USD300,000 - USD320,000 per year.

Schedule

- Hybrid.