Quality Control Engineer - CFR, CAPA

Level of

Experience:

Mid-Level

Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)

Position: Quality Control Engineer

Location: Sandy, UT

Duration: 06 Months

Total Hours/Week: 40 hours

Shift: 1st Shift

Client: Medical Devices Company

Job Category: Technical

Core

Hours:

8 am - 5 pm, Mon - Fri

• GMP professional to support CAPA deliverables as part of a broader quality remediation initiative, bringing strong knowledge of 21 CFR Part 211 requirements and demonstrated expertise in technical writing and document review within a regulated environment.
• The ideal candidate will be capable of independently driving high-quality, inspection‑ready outputs while partnering with cross‑functional teams and contributing to a risk‑based approach to compliance, with additional value placed on familiarity with ICH Q9 principles.

• Develop and execute CAPA records, ensuring alignment with regulatory expectations and internal quality standards.
• Perform thorough technical writing and critical review of investigations, protocols, and reports.
• Apply 21 CFR Part 211 knowledge to ensure GMP compliance across deliverables and identify potential risks or gaps.
• Collaborate with SMEs and functional teams to drive timely closure of CAPAs and maintain project timelines.
• Additional desired skills in risk assessment and risk management to contribute to or author/review risk assessments using a structured, science‑and‑risk‑based approach (ICH Q9 experience preferred).