Post Market Quality Technician, Medical Device
Overview
You own post-market quality assurance for medical devices in a contract role at Apex Systems, supporting a client in Acton, MA. You review complaints, analyze trends, and drive corrective actions to keep products safe and compliant. You join a team of quality engineers and work directly with manufacturing and regulatory affairs. This 3-month project offers a chance to apply ISO 13485 and FDA QSR standards in a hands-on role.
What You'll Do6
- 1Review and document customer complaints for medical devices, ensuring accurate classification per ISO 13485 and FDA QSR.
- 2Trend and analyze post-market data using Excel and CAPA systems, identifying signals for corrective action.
- 3Write and update complaint investigation reports, coordinating with engineering and manufacturing teams.
- 4Execute and track corrective and preventive actions, verifying effectiveness and closure timelines.
- 5Prepare and present monthly quality metrics to management and cross-functional stakeholders.
- 6Support internal and external audits by providing evidence of complaint handling and CAPA activities.
Requirements5
- 12+ years in post-market quality assurance within medical devices or regulated industries.
- 2Hands-on experience with CAPA, complaint handling, and root cause analysis tools like 5 Whys and FMEA.
- 3Working knowledge of ISO 13485 and FDA 21 CFR Part 820 regulations.
- 4Proficiency in Microsoft Excel for data analysis and trend reporting.
- 5Strong attention to detail and documentation practices in a quality system environment.
Salary Insight
$67k per year
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