Product Quality Engineer

Title: Product Quality Engineer

Location: Marlborough MA - Onsite

Duration: 06 months

Job Summary:

• Provide Product Quality Engineering support on risk management and product complaint trending.
• This role will be responsible for reviewing each complaint record individually and identifying the appropriate risk lines and associated severities from the product's Risk Management File (RMF) that relate to what was reported by the complainant and the results of the investigation.
• In partnership with Product Quality Engineering and Post Market Quality Engineering, the qualified contractor will perform assessments, identify potential updates to the RMF, and perform trend analysis per the applicable quality procedures.
• 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 for applicable quality procedures.

Education:

• BS in biomedical engineering, mechanical engineering, or health care related discipline.

Experience:

• Minimum 1 year working with medical devices or other highly regulated industry, Quality Engineering experience preferred.

Skills

• 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
• Basic knowledge of medical terminology and anatomy
• Basic knowledge of engineering and process terminology
• Understanding of statistics including statistical process control (SPC)
• Minitab experience preferred.

Preferred:

• Experience authoring and executing risk assessments
• Working knowledge of ISO14971, 21 CFR 803 and 21 CFR 820