CAPA Execution Specialist / Investigator

CAPA Execution Specialist / Investigator

Location: Delaware (Onsite)

Duration: 12 months (potential extension up to 24 months)

Type: Contract (W2)

Rate/Salary: $55–$60/hour

This is a contract role, and employer-provided benefits are not applicable

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 $B"(J root cause $B"(J solution $B"(J implementation $B"(J 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