Quality Assurance Engineer

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.

• ◆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

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.

• ✓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

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

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

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

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com .

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.