Quality Senior Engineer I
Englewood, Colorado, United States
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.
