Description
We are working alongside our key client in the Medical Diagnostic sector based in San Antonio, to hire a Quality Control Lab Manager.
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
A global organisation operating in the Medical Diagnostic Manufacturing industry.
The Role
As a Quality Assurance Manager, you will play a pivotal role at our South Bend, Indiana site. You will lead and direct quality assurance and regulatory activities to ensure that our products meet the highest standards of quality and compliance. Plans coordinates, and directs QA and regulatory activities, either directly or via delegates, to maintain continuous product manufacturing that aligns with the Quality Management System and regulatory standards, emphasizing organizational compliance.
Requirements\Qualifications
- Bachelor's degree (B.A. /B.S.) from an accredited college or university in a science-related field.
- Authorised 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, and 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.
- Strong Root Cause Analysis skills (5 whys, Fishbone Diagrams, etc).
