What are the responsibilities and job description for the CAPA Execution Specialist / Investigator position at IT Minds LLC?
CAPA Execution Specialist / Investigator (Contract – Onsite, Delaware)
Logistics
- Location: Onsite, Delaware (no remote flexibility)
- Duration: 12 months to start, potential extension up to 24 months
- Team Size: 5 CAPA execution-focused resources
- Environment: Medical device manufacturing (electromechanical assembly focus)
Must-Have Experience
- Hands-on CAPA execution experience within medical device manufacturing (not facilitation or program management)
- Strong background in root cause analysis (5 Whys, Fishbone, etc.) with proven implementation of corrective and preventive actions
- Experience working directly on the manufacturing floor, ensuring adherence to procedures and driving real-time corrections
- Demonstrated ability to own CAPAs end-to-end: investigation → root cause → solution → implementation → verification of effectiveness
- Experience with electromechanical assembly CAPAs or CAPEX environments (highly relevant); disposables and systems CAPAs also acceptable
- Familiarity with document control systems and implementing procedural updates tied to CAPAs
- Background in Mechanical, Biomedical, or Quality Engineering within a regulated environment (FDA / ISO)
Day-to-Day Responsibilities
- Execute assigned CAPAs with full ownership and accountability (no facilitation role)
- Perform root cause investigations using structured problem-solving tools (e.g., 5 Whys)
- Define and implement corrective and preventive actions on the manufacturing floor
- Work hands-on with assembly teams to ensure procedural compliance and proper execution
- Identify required updates to SOPs, work instructions, and quality documentation
- Drive implementation of changes within document control systems (including manual/Agile-based processes)
- Verify effectiveness of CAPAs and ensure sustainable fixes are in place
- Partner cross-functionally with Quality, Manufacturing, and Engineering teams to execute solutions
Nice to Have
- Experience with Agile or hybrid document control systems
- Prior exposure to capital equipment manufacturing environments
- Experience balancing multiple CAPAs simultaneously in a fast-paced setting
- Familiarity with both systems-level and manufacturing CAPAs
- Ability to quickly integrate into teams and operate as a high-output “doer”