Description
Industry
Medical and Life Sciences – Diagnostics
Who we are
We are a dynamic recruitment and executive search agency that has evolved since our first establishment in 2012. We work with several high-profile clients, start-ups, and SMEs globally to help them source and retain top-tier talent.
The client
Our client is a global Medical Diagnostic company that manufactures a range of molecular diagnostics and clinical diagnostics equipment that aids in rapid disease testing for physicians and patients. The organisation takes pride in developing products that contribute to quality healthcare with business across both the US and Europe, offering a range of Rapid Tests, Chemistry Reagents, and Point of Care devices to identify and monitor diabetes.
The Role
Responsible for overseeing and leading the Quality Assurance department at the Boerne, Texas site. This role directs and coordinates all QA activities—either personally or through team leadership—to ensure consistent product quality and compliance with the Quality Management System. Ensures all manufactured products and services meet applicable regulatory and quality standards, with a strong focus on continuous improvement and organizational compliance.
Requirements\Qualifications
- Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science-related field.
- Authorized to work in the United States.
- 5 years of quality and regulatory experience in relation to medical devices or In vitro diagnostics devices.
- Minimum of two years of supervisory experience.
- Strong knowledge of various standards and regulations such as ISO 13485, ISO 14971, the Quality System Regulation (21 CFR Part 820)
- Knowledge of other applicable country regulatory requirements such as the EU IVDD/IVDR and the UK MDR, etc.
