Quality Engineer
Full-time
Lorven Technologies Inc
Hi
Our client is looking for a Quality Engineer project in Reedsville, PA below is the detailed requirements.
Job Title : Quality Engineer
Location : Reedsville, PA
Required Skills : Medical Device Manufacturing, Process Validation
Job description:
- Bachelor's degree in computer science, Information Technology, or a related field
- 8+ years of Medical Device Manufacturing Quality experience .
- Experience with Class II/III medical devices .
- Experience supporting regulatory audits and inspections .
- Strong experience in manufacturing process improvement and quality risk reduction.
- Lead manufacturing quality assessments and process audits .
- Drive First Pass Yield (FPY) improvement and defect reduction initiatives.
- Review process validation (IQ/OQ/PQ) and risk management activities.
- Manage CAPA, nonconformance, and supplier quality issues .
- Support FDA, ISO 13485, MDSAP, and regulatory audits/inspections .
- Analyze manufacturing quality metrics and identify opportunities for continuous improvement.
- Drive manufacturing risk reduction and quality improvement initiatives.
Vacancy posted 3 days ago
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