Quality Engineer III
My client is a leading innovator of women's health and is looking for an individual to join their Quality Team to work directly on their diagnostic and treatment equipment. Their portfolio ranges from screening technologies to molecular and cytology diagnostics. They are a large enough company to invest in people and new technology, but small enough to ensure that every single employee can directly impact the business and drive real change for good.
- Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).
- Provide Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development.
- Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
- Assist in development, maintenance, and reporting of department metrics.
- Train and mentor new employees. Provide guidance and direction to the team.
- Bachelor's degree in Science or Engineering
- 4-7 years of experience in in in-vitro diagnostic, medical device industry.
- Advance knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).
- Advance knowledge of 21 CFR Part 11.
Competitive benefits on top of a high base salary
If you're interested, don't wait to apply!