What are the responsibilities and job description for the Quality Engineer position at Primesoft Consulting Services Inc?
Job Details
Position: Quality Engineer
Duration : 12 Months
Location: Pittsburgh, PA
Mode of Work: Hybrid
Visa: Independent status consultants
No C2C Job Description:
Bachelor s degree in Engineering, Quality, or a related field (Master s preferred).
5 years of experience in medical device quality engineering or a related field.
Strong knowledge of ISO 13485, FDA QSR (21 CFR Part 820), EU MDR, and risk management (ISO 14971).
Experience with Design Control, Process Validation, CAPA, and Supplier Quality.
Proficiency in statistical analysis tools (Minitab, JMP, Excel) /and problem-solving methodologies (8D, DMAIC).
Certified Quality Engineer (CQE) or Six Sigma certification is a plus.
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