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Senior Quality Engineer
Job in
Santa Clara, Santa Clara County, California, 95053, USA
Listed on 2026-08-04
Listing for:
Intellectt Inc
Full Time
position Listed on 2026-08-04
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Job Description & How to Apply Below
- Support Quality Systems & Compliance activities
- Manage KPI dashboards and quality/compliance metrics
- Support internal and external audits, including audit preparedness
- Investigate CAPAs, non-conformances, and process improvement opportunities
- Drive corrective actions and mitigation strategies
- Process change orders and quality system updates
- Collaborate with cross-functional teams to ensure compliance
- Manage multiple quality and compliance projects simultaneously
- 5–7 years of Quality Engineering experience in the medical device industry
- Quality Systems & Compliance
- Internal & External Audit Support
- Change Management / Change Orders
- Process Improvement
- Strong troubleshooting, analytical, and problem-solving skills
- Power BI
- Knowledge of FDA regulations, ISO 13485, and EU MDR
- Windchill
- Manufacturing Quality Engineering
- Audit Planning & Risk Mitigation
- Bachelor's degree in Engineering, Life Sciences, or a related field (Preferred)
Position Requirements
10+ Years
work experience
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