Sr Quality Engineer
Artech
Job Title: Sr. Quality Engineer
Job ID: 26546
Duration: 6 months
Location: 1480 Arthur Ave, Unit D, Louisville Colorado 80027
Pay Range: $55-60.00/hr. on W2 Key Responsibilities:
Education: B.S. in Engineering
Experience: 7-10 years in Medical Device Quality Engineering
Work Schedule: 40 hrs/week, 100% Onsite
Job ID: 26546
Duration: 6 months
Location: 1480 Arthur Ave, Unit D, Louisville Colorado 80027
Pay Range: $55-60.00/hr. on W2 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.
- 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
Vacancy posted 3 days ago
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