Product Quality Engineer
Full-time
SGS Consulting
Job Responsibilities:
- Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs.
- Analyze complaint information and identify hazardous situations and harms reported through complaint information
- Evaluating content in existing Risk Management Files ensuring all hazardous situations and harms reported through complaint information is adequately captured.
- Perform trend analysis using Statistical Process Controls per applicable quality procedures.
Skills:
- Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred
- Experienced with Quality System Regulations, ISO 13485 and 21 CFR 820.
- Experienced with ISO 14971, Risk Management
- Basic knowledge of risk analysis techniques such as FMEAs
Education/Experience:
- BS in biomedical engineering, mechanical engineering, or health care related discipline
Vacancy posted 5 days ago
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