What are the responsibilities and job description for the Quality Control Engineer - [21 CFR, CAPA Required] position at MillenniumSoft Inc?
Position : Quality Control Engineer
Location : Sandy, UT
Duration : 06 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Technical
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)
Note
Core Hours will be between 8 am-5pm Mon-Fri
Job Description
Location : Sandy, UT
Duration : 06 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Technical
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)
Note
Core Hours will be between 8 am-5pm Mon-Fri
Job Description
- 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)