Quality Assurance Engineer
About The Position
The Product Quality Assurance Engineer supports product quality throughout the product lifecycle, with a focus on complaint investigations, risk management support, and product quality monitoring. The role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to investigate issues, analyze product performance, and contribute to improvements in product reliability, patient safety, and compliance for medical devices. The position supports product and complaint investigations, risk management, complaint and field-performance data analysis, CAPA and nonconformance activities, design reviews, and design verification and validation quality processes. It also maintains investigation and quality records, supports compliance with regulatory requirements and quality system standards, and contributes to continuous improvement. The role is hybrid/remote with occasional travel as needed.
Requirements
- Bachelor's degree in Engineering or a related technical discipline.
- At least 2 years of experience in quality engineering, product quality, or product engineering.
- Basic understanding of engineering principles, data analysis, and problem-solving techniques.
- Strong organizational skills and attention to detail, including 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, including the ability to 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.
- Advanced English.
Nice To Haves
- Experience in a regulated industry.
- Internship, co-op, or early-career experience in medical devices, manufacturing, or a regulated industry.
- Experience using quality system tools or data analysis tools.
- Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971.
Responsibilities
- Assist with product and complaint investigations, including data gathering, product failure analysis, and root cause analysis activities.
- Support product risk management activities, including documentation updates, risk assessments, and maintenance of risk management files.
- Analyze complaint, service, and field performance data to identify trends, recurring issues, and opportunities for product quality improvement.
- Support CAPA and nonconformance activities related to product quality issues, including documentation, tracking, and follow-up actions.
- Participate in product design reviews and quality assessments to help ensure quality requirements are addressed throughout the product lifecycle.
- Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams to resolve product quality issues.
- Support design verification and validation quality activities through documentation review and participation in related quality processes.
- Ensure product quality activities comply with applicable regulatory requirements, quality system standards, and internal procedures.
- Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
- Contribute to continuous improvement initiatives related to product quality, field performance, and quality system effectiveness.
Benefits
- Eligible for an annual bonus in accordance with the company's bonus plan.
- Comprehensive benefits plans are available; specific benefits are not detailed in the posting.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
