Product Quality Assurance Engineer

Job Summary

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. This role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to support investigations, analyze product performance, and contribute to activities that improve product reliability, patient safety, and compliance for medical devices.

Essential Functions

• Assist with product and complaint investigations, including data gathering, product failure analysis, and support for root cause analysis activities.
• Support product risk management activities, including documentation updates, risk assessments, and maintenance of risk management files in accordance with applicable standards and procedures.
• 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 support resolution of product quality issues.
• Support design verification and validation quality activities through review of documentation and participation in related quality processes.
• Ensure product quality activities are performed in compliance 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.

Required/Preferred Education and Experience

• 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.
• Experience using quality system tools or data analysis tools is a plus.

Knowledge, Skills and Abilities

• 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 is a plus

Preferred Languages

• English - Advanced

Travel Requirements

• Hybrid/Remote role with occasional travel as needed for team meetings, training, investigations, audits, or site support

Physical Demands

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently