Vice President of Quality Assurance
Confidential
Vice President of Quality Assurance
About the Company
An established medical device company with a commercial implantable portfolio.
Industry
Medical Devices
Type
Privately Held
About the Role
The Company is seeking a Vice President of Quality Assurance to take on a full-ownership quality seat at the VP level. The successful candidate will be responsible for the Quality Management System, including audits, documentation, CAPA, calibration, training, and management reviews. This role demands an enterprise quality leader with the authority to oversee internal staff and contract manufacturers, ensuring compliance with both domestic and global quality system requirements. The VP will also be involved in leading complaint handling, reportability determinations to regulatory agencies, and supporting various quality assurance activities across the commercial portfolio. Applicants must have a minimum of 10-12 years' experience in Quality Assurance and/or Product Development Engineering within the implantable medical device industry, with a proven track record of leading quality teams and cross-functional accountability. The role requires a deep working knowledge of FDA regulations, ISO standards, and international GMP requirements. The ideal candidate will have prior experience as a functional leader at the Director or VP level and be adept at managing document control, product release, non-conforming product, and return/repair programs. The position is suited for an individual who is ready to take on the challenge of enterprise-wide quality leadership in a high-stakes device environment.
Functions
- Operations
Vacancy posted 5 days ago
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