More jobs:
Quality Engineer
Job in
Sandy, Salt Lake County, Utah, 84070, USA
Listed on 2026-06-03
Listing for:
Sunrise Systems Inc
Contract
position Listed on 2026-06-03
Job specializations:
-
Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Our client, a leading Medical Device Manufacturing Company is looking for Quality Engineer 3 and This is for an initial duration of 06 Months Contract – Sandy, UT
Job Title:
Quality Engineer 3
Job
-02510
Location:
Sandy, UT
Duration: 06 Months Contract
Position Type:
Hourly Contract Position (W2 only)
Technical Skills
Must Have
- 21 CFR Part 210/211
- BS in scientific/technical field (or equivalent experience)
- Direct CAPA authoring
- Investigation writing
- Pharmaceutical/Drug Manufacturing
- Technical Review
Nice To Have
- Cleaning Validations
- Equipment Validation, Transfer, and Qualification
- ICH Q9
- OOS Investigations
- Supplier Assurance
Job Description
- Core Hours will be between 8 am-5pm Mon-Fri
- Temporary (6-month) contract
- 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)
Thank You.
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×