Post Market Quality Technician

Advantage Technical

Acton (MA)

On-site

USD 36,000 - 52,000

Full time

10 days ago

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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

Now Hiring: Post Market Quality Technician

Location: Acton, MA

Pay Rate: Up to $32.00/hour

Schedule: On-site, Monday-Friday | Start time between 6:00 AM and 8:00 AM

Are you experienced in quality assurance, failure analysis, or regulated manufacturing environments? We are seeking a detail-oriented Post Market Quality Technician to support quality investigations, product testing, and compliance activities for FDA-regulated products. This temporary opportunity is ideal for candidates who enjoy hands-on technical work, data analysis, and collaborating with cross-functional teams to improve product quality and reliability.

Key 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 opportunities for improvement
  • Investigate product issues and troubleshoot emerging failure modes
  • Partner with Quality Engineers and Operations teams to improve processes, safety, and product performance
  • Assist during FDA and ISO audits and inspections
Qualifications
  • Associate Degree in Engineering, Science, or a related technical field
  • Experience in quality, manufacturing, laboratory, medical device, or other regulated industries preferred
  • Knowledge of QSR, FDA regulations, ISO 13485, CAPA, and quality systems is a plus
  • Electrical and mechanical troubleshooting experience preferred
  • Proficiency with Microsoft Excel and data analysis tools
  • Strong technical writing, documentation, and organizational skills
  • Experience with Lean Six Sigma methodologies is beneficial
Employee Benefits
  • Medical, Dental, Vision, and Pet Insurance
  • 401(k) Retirement Savings Plan
  • Employee Assistance Program (EAP)
  • Commuter/Parking Accounts
  • People Perks
  • Health Savings Account (HSA)
  • AD&D Insurance

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depends on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

About Us

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.

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