Quality Senior Engineer I

IDR is seeking a Quality Senior Engineer I to join one of our top clients for an opportunity in Englewood, CO. This role involves supporting CAPA remediation and quality system compliance activities within a regulated medical device environment. The company is a leader in medical device manufacturing, emphasizing quality assurance and compliance. Position Overview for the

Quality Senior Engineer I:

Support CAPA remediation and quality system compliance activities within the QARA organization. Review, remediate, and migrate legacy CAPA records into EtQ to ensure regulatory and procedural compliance. Manage CAPA workflows from initiation through closure, including investigation support and effectiveness verification. Collaborate cross-functionally with Quality, Regulatory, Operations, and Engineering teams to support remediation and quality efforts. Maintain accurate technical documentation and support audit/readiness activities. Requirements for the

Quality Senior Engineer I:

3-5 years of Quality Engineering experience supporting CAPA processes Experience within a regulated industry environment, preferably medical device Working knowledge of CAPA processes, root cause analysis, and quality systems Experience with electronic Quality Management Systems (EtQ strongly preferred) Knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and risk-based quality principles What's in it for you? Competitive compensation package Full Benefits; Medical, Vision, Dental, and more! Opportunity to get in with an industry leading organization. Why IDR? 25+ Years of Proven Industry Experience in 4 major markets Employee Stock Ownership Program Dedicated Engagement Manager who is committed to you and your success. Medical, Dental, Vision, and Life Insurance ClearlyRated's Best of Staffing® Client and Talent Award winner 12 years in a row.