Product Quality Engineer

Job Title: Product Quality Engineer
Location: Marlborough, MA 01752
Duration: 3 Months+ (Possible Extension)
 
Pay Range: $45 - $70/hr. on W2
 
Start Date: ASAP
 
Job Summary:
The Product Quality Engineer/Project Manager will support risk management and complaint trending for medical devices or other highly regulated products. The role includes reviewing complaint records, identifying associated risks from the Risk Management File (RMF), performing assessments and trend analyses, and partnering with Product Quality Engineering (PQE) and Post Market Quality Engineering (PMQE).
 
Essential Duties:

• Analyze complaint information to identify hazardous situations and harms
• Review existing RMFs to ensure all hazardous situations and harms are captured
• Perform trend analysis using Statistical Process Controls (SPC) per quality procedures
• Collaborate with PQE, PMQE, and Post Market Analytics teams
• Perform assessments and recommend RMF updates as needed
• Contribute to project teams and take leadership on critical tasks to ensure timely completion
• Maintain accuracy, compliance, and timely communication with escalation of issues

 
Education:

• Required: BS in Biomedical Engineering, Mechanical Engineering, or healthcare-related discipline

 
Experience:

• Required: Minimum 1 year working with medical devices or other highly regulated industry
• Preferred: Quality Engineering experience, authoring and executing risk assessments

 
Skills & Knowledge:
Required:

• Quality System Regulations, ISO 13485, 21 CFR 820
• ISO 14971, Risk Management
• Basic knowledge of FMEAs, medical terminology, anatomy, engineering, and process terminology
• Understanding of statistics, including SPC (Minitab preferred)
• Detail-oriented, accountable, and reliable
• Collaborative team player with effective communication

 
Preferred:

• Experience authoring/executing risk assessments
• Working knowledge of ISO 14971, 21 CFR 803, 21 CFR 820

 
Physical Demands:

• Sit and use hands to handle objects, tools, or controls
• Stand, walk, reach, stoop, kneel, crouch, or crawl
• Reasonable accommodations provided per ADA

 
Key Success Factors:

• Ability to analyze product complaints and associated risk
• Ability to perform trend analysis and recommend RMF updates
• Effective teamwork and communication with cross-functional and international teams
• Strong attention to detail, compliance, and regulatory understanding