Medical Device Quality Engineer – Risk & Compliance

SGS Consulting; Boston (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

SGS Consulting seeks a Quality Engineer for a regulated medical device environment in Boston, MA. You will analyze complaints, evaluate risk, and perform trend analysis under SOPs and quality system requirements.

Candidates should have a BS in a relevant field and hands-on experience with ISO 13485, ISO 14971, and FMEAs; familiarity with 21 CFR 820 is a plus. This role emphasizes risk management, compliance, and cross-functional collaboration.

Qualifications

• 1+ year working with medical devices or regulated industry; quality engineering experience preferred
• Experience with Quality System Regulations, ISO 13485 and 21 CFR 820
• Experience with ISO 14971 and risk management
• Basic knowledge of risk analysis techniques such as FMEAs

Responsibilities

• Analyze complaint information and identify hazardous situations and harms reported through complaint information
• Evaluate content in existing Risk Management Files ensuring all hazards are captured
• Perform trend analysis using Statistical Process Controls per applicable quality procedures

Skills

Medical devices experience

Quality System Regulations

ISO 13485

21 CFR 820

ISO 14971

Risk Management

FMEAs

Education

BS in biomedical engineering or related discipline

Job description

SGS Consulting seeks a Quality Engineer for a regulated medical device environment in Boston, MA. You will analyze complaints, evaluate risk, and perform trend analysis under SOPs and quality system requirements.

Candidates should have a BS in a relevant field and hands-on experience with ISO 13485, ISO 14971, and FMEAs; familiarity with 21 CFR 820 is a plus. This role emphasizes risk management, compliance, and cross-functional collaboration.