Vice President, Quality Assurance

Vice President, Quality Assurance

About the Company

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

Industry
Medical Devices

Type
Privately Held

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 also be expected to have a deep understanding of FDA regulations, ISO standards, design controls, CAPA, and risk management, as well as a proven track record in supporting clinical studies and regulatory inspections. Applicants for the VP of Quality Assurance position at the company should possess the ability to build and lead high-performing quality organizations and be adept at partnering with cross-functional teams, including regulatory affairs, clinical affairs, R&D, and operations. The role offers the opportunity to work with an innovative cardiovascular pipeline and requires a leader who can ensure the highest quality standards are maintained throughout the product lifecycle. The ideal candidate will be a strategic thinker, capable of driving quality initiatives that align with the company's growth and expansion in the medical device industry.

Functions

• Operations