Quality Lead Engineer (Medical Device Validation)
Lorven Technologies Inc
Hi,
Our client is looking for Quality Lead Engineer (Medical Device Validation) - Reedsville, PA below is the detailed requirements.
Job Title: Quality Lead Engineer (Medical Device Validation)
Location: Reedsville, PA
Job Description:
- Bachelor's degree in Computer Science, Information Technology, Engineering, or related field with 8 12 years of overall IT experience.
- 8+ years of Medical Device Quality experience.
- Experience with Class II/III medical devices.
- Experience supporting FDA, MDSAP, and ISO audits
- Manage CAPA, Nonconformance, and Deviation activities.
- Conduct Root Cause Analysis and corrective actions.
- Review quality metrics and identify recurring issues.
- Support quality audits and FDA readiness programs.
- Collaborate with cross-functional teams on quality improvements.
Required Skills:
- CAPA, Nonconformance, and Deviation Management.
- Root Cause Analysis (5 Why, Fishbone, FTA).
- Quality Metrics and Trend Analysis.
- FDA 21 CFR Part 820, ISO 13485, ISO 14971.
- Design Controls and Validation Support
Vacancy posted 2 days ago
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