Post Market Complaint Analyst, Medical Devices
Overview
Own post-market surveillance and complaint investigations for hearing enhancement and wearable technology programs at Apex Systems. You will drive root cause analysis and support CAPA activities within a regulated QMS. Partner with quality and engineering teams to ensure customer satisfaction and regulatory compliance. This role demands precision in documenting and resolving product issues.
What You'll Do8
- 1Manage incoming product complaints, documenting each case in the QMS with accurate details.
- 2Conduct root cause investigations for reported issues, using tools like 5 Whys and Fishbone.
- 3Coordinate with engineering to implement corrective actions and track CAPA effectiveness.
- 4Prepare and submit regulatory reports, including MDR and Vigilance filings, within required timelines.
- 5Analyze complaint trends to identify emerging product risks and support PMS activities.
- 6Collaborate with customer service to gather additional data and resolve customer quality issues.
- 7Facilitate monthly complaint review meetings with cross-functional teams.
- 8Support internal and external audits by providing complaint records and investigation summaries.
Requirements7
- 13+ years in post-market surveillance or complaint handling within medical devices.
- 2Hands-on experience with CAPA and root cause analysis methodologies.
- 3Working knowledge of ISO 13485 and FDA 21 CFR Part 820 regulations.
- 4Proficiency with QMS software such as TrackWise or MasterControl.
- 5Strong analytical skills with ability to interpret complex product data.
- 6Excellent written communication for regulatory documentation.
- 7Bachelor's degree in engineering, life sciences, or related field.
Salary Insight
$73 - $94k per year
Location
Required Skills
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