Product Quality Assurance Engineer
$82,400–$90,000 year
HybridChelmsford, Massachusetts, United States
Job Summary
Conduct product and complaint investigations through data gathering, failure analysis, and root cause support. Support risk management activities by updating documentation, performing risk assessments, and maintaining regulatory files. Analyze field performance data to identify trends and drive continuous quality improvement initiatives. Manage CAPA and nonconformance activities, including tracking follow-up actions and ensuring compliance with FDA and ISO standards. Partner with Engineering, Manufacturing, Regulatory, and Post-Market teams to resolve product quality issues and participate in design verification processes. Maintain accurate documentation of all investigations and quality records.
Required Qualifications
- Bachelor's Degree in Engineering or a related technical discipline
- 2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry
- Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry
- Basic understanding of engineering principles, data analysis, and problem-solving techniques
- Strong organizational skills and attention to detail, with the ability to manage documentation and follow established processes
- Ability to work collaboratively in a cross-functional team environment
- Strong written and verbal communication skills, with the ability to clearly document findings and communicate with technical stakeholders
- Ability to work effectively in a remote environment while collaborating across teams and time zones
- Familiarity with complaint handling, CAPA, nonconformance systems, or risk management processes
- Exposure to medical device design controls, verification and validation, or post-market quality activities
- Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971
- English - Advanced
- Occasional travel as needed for team meetings, training, investigations, audits, or site support
Desired Qualifications
- Experience using quality system tools or data analysis tools is a plus
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