Post-Market Quality Technician: QA & Failure Analysis

Advantage Technical; Acton (MA); On-site; USD 36,000 - 52,000; Full time

Benefits offered by this job

Medical insurance

401(k) Retirement Savings Plan

Employee Assistance Program (EAP)

Commuter/Parking Accounts

Health Savings Account (HSA)

AD&D Insurance

Job summary

Advantage Technical in Acton, MA is seeking a Post Market Quality Technician to support FDA-regulated quality investigations, product testing, and CAPA activities. This on-site temporary role emphasizes hands-on testing, data analysis, and collaboration with cross-functional teams to improve product quality and reliability.

The ideal candidate has an Associate Degree in Engineering or Science and experience in regulated environments, plus proficiency with Excel and quality systems; familiarity

Qualifications

• Associate degree in engineering, science or related field preferred.
• Experience in quality, manufacturing, laboratory, medical device, or regulated industries beneficial.
• Knowledge of QSR, FDA regulations, ISO 13485, CAPA, and quality systems valued.

Responsibilities

• Conduct product testing, inspections, and failure analysis investigations.
• Support post-market quality activities and regulatory compliance efforts.
• Create, review, and maintain quality system documentation including CAPA, NCRs, training records, and audit documentation.
• Review device history records (DHRs) and lot acceptance documentation.
• Collect, trend, and analyze quality data to identify improvement opportunities.
• Investigate product issues and troubleshoot failure modes.
• Collaborate with Quality Engineers and Operations to improve processes and product performance.
• Assist during FDA and ISO audits and inspections.

Skills

Data analysis

Excel proficiency

Technical writing

Regulatory knowledge

Education

Associate Degree in Engineering/Science

Tools

CAPA tracking tools

DHR review tools

Job description

Advantage Technical in Acton, MA is seeking a Post Market Quality Technician to support FDA-regulated quality investigations, product testing, and CAPA activities. This on-site temporary role emphasizes hands-on testing, data analysis, and collaboration with cross-functional teams to improve product quality and reliability.

The ideal candidate has an Associate Degree in Engineering or Science and experience in regulated environments, plus proficiency with Excel and quality systems; familiarity