Sr Quality Engineer
Job in
Louisville, Boulder County, Colorado, 80027, USA
Listed on 2026-07-03
Listing for:
Artech
Full Time
position Listed on 2026-07-03
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Sr. Quality Engineer
Key Responsibilities:
- Review/approve Non-Conformances (NCMRs), Document Changes, and Validation documents.
- Perform QMS harmonization by aligning local procedures with enterprise QMS requirements.
- Review/write technical procedures and update controlled documents.
- Lead Gemba Walks, identify risks, and drive corrective actions.
- Support CAPA, quality documentation, inspections, testing, statistical analysis, process improvements, and regulatory compliance.
- Collaborate with Engineering and Manufacturing while managing both daily operational tasks and long-term projects.
Required Skills:
- Technical procedure review & writing.
- Strong knowledge of FDA, ISO 13485, and NCMR requirements.
- Experience with QMS/document control, validations, CAPA, risk management, and quality systems.
- Ability to prioritize multiple assignments and work independently.
- Strong communication and cross-functional collaboration skills.
Education:
B.S. in Engineering
Experience:
7–10 years in Medical Device Quality Engineering
Work Schedule:
40 hrs/week, 100% Onsite
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