Product Quality Engineer

SGS Consulting
Massachusetts

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
Posted 2025-12-08

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