Sr. Quality Engineer (Contract-to-Hire)
Location: On-Site in Greater Boulder Area, CO
Targeted Start: ASAP
*This project is NOT considering partnering with third party vendors*
Assignment Overview:
Our client is an innovative medical device manufacturer who is developing novel therapies to restore the lives of patients around the world. Our client needs a Sr. Quality Engineer to support their team with NCMRs and post market surveillance.
Primary Responsibilities:
- Support R&D projects and quality engineering activities
- Support quality team’s electronic quality system including NCMRs, CAPAs, and Complaints
- Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development
- Perform pre and post market surveillance activities
- Perform statistical analysis on all V&V activities
Technical Requirements:
- BS Degree in Engineering or Life Sciences preferred
- 5+ years of medical device quality engineering experience
- Strong background and understanding of NCMR's
- Experience writing and executing validation protocols and reports
- Strong understanding of FDA QSR and ISO 13485 requirements