Quality Engineer - Onsite; Part time

Job Category

Engineering

Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT). This position is part-time 20-30 hours per week.

Quality Engineer

Sandy, UT

6 Months

40.00

1st Shift

Medical Devices Company

• 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).