Job Title : Staff Quality Assurance Engineer
Location : California (Site-based)
Industry : Medical Device
Salary : Competitive & Great Benefits
Skills Alliance has joined forces with a pioneering Cardiology company dedicated to revolutionizing cardiac care through cutting-edge interventions.
Introducing ground-breaking technologies for heart failure, my client is reshaping the landscape of a $3 billion market, enhancing patient outcomes globally!
We are interested to hear from Staff Quality Engineers leaders with cardiology experience seeking a step up. If you enjoy product development, Quality Assurance, Design Control and ISO : 13485 then this is THE role for you!
Requirements :
- 5-7 years’ quality assurance experience in cardiovascular medical technology
- Lead the engineering teams in the quality approvals, design assurance, QMS
- Device experience in Class III cardiac implants including catheter, hardware, and electrical systems
Responsibilities :
- Ensure design capability by means of comprehensive technical reviews, testing, and robust documentation
- Oversee and understand project risks ensuring mitigation and contingency plans are established and activated as required
- Ensure that the Quality System is compliant with 21 CFR 820, 803, 806 and ISO 13485.
- Experience with FDA Design Controls, Class III Implants, AIMD and Engineering Change Management procedures for medical device development is required
- Support preparation and maintenance of compliance to ISO 14971 Risk Management.
Apply here if you are interested in this opportunity or if you would like a confidential discussion about your career opportunities, please contact Shakir Hossain in confidence on +1 929 371 6732 or shakir.
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