QMS Analyst, Post-Market Surveillance & Complaint Investigations
Overview
This role owns post-market surveillance and complaint investigations for regulated hearing enhancement and wearable tech products. You'll drive root cause analysis and CAPA support within a QMS framework. You'll work with cross-functional teams on customer quality issues. This position stands out for its focus on end-to-end quality compliance in a regulated medical device environment.
What You'll Do6
- 1Own complaint investigations from intake to closure, using QMS tools to document findings.
- 2Drive root cause analysis for product complaints, applying CAPA methodologies.
- 3Coordinate post-market surveillance activities for hearing enhancement and wearable devices.
- 4Support customer quality activities, ensuring timely response and resolution.
- 5Collaborate with engineering and regulatory teams to implement corrective actions.
- 6Maintain compliance with ISO 13485 and FDA regulations in all quality processes.
Requirements6
- 13+ years experience in quality systems within a regulated industry (medical devices or similar).
- 2Hands-on experience with complaint handling and root cause analysis using CAPA.
- 3Strong knowledge of QMS software (e.g., MasterControl, TrackWise) is preferred.
- 4Familiarity with ISO 13485, FDA 21 CFR Part 820, and MDR regulations.
- 5Bachelor's degree in engineering, life sciences, or related field.
- 6Audit experience or certification (e.g., ASQ CQA) is a plus.
Salary Insight
$73 - $94k per year
Location
Required Skills
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