Allison Jones

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.