Product Quality Engineer
Listed on 2026-10-18
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Engineering
Quality Engineering, Biomedical Engineer
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.
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
Experience:
BS in biomedical engineering, mechanical engineering, or health care related discipline
We would love to welcome a new Product Quality Engineer to our organisation in Boston, MA, United States.
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