Overview
Senior Quality Engineer Jobs in Boulder, CO at Ardence Consulting
Title: Senior Quality Engineer
Company: Ardence Consulting
Location: Boulder, CO
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
