Quality Engineer

Role: Quality Engineer

Location: Sandy, UT(Onsite)

Durtation: 6+Months(Contract W2 with Medical benefits)

Client: Medical

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.

key capabilities include:

• 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)

Kindly share resume at ***email_hidden*** or call me at 678-935-7045 to discuss more!