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
Product Quality Engineer in massachusetts at Unknown Company
This position is listed as full time and onsite.