Quality Assurance Engineer, Product

About The Company

ZOLL Medical Corporation is a global leader in medical technology dedicated to improving patient outcomes and saving lives. With a commitment to innovation, ZOLL provides advanced devices, software, and related services used worldwide to diagnose and treat serious cardiopulmonary and respiratory conditions. The company's focus on lifesaving solutions spans across various sectors including emergency medical services, hospitals, public safety, and military applications. Operating in more than 140 countries, ZOLL fosters a culture of innovation, self-motivation, and entrepreneurial spirit, aiming to make a meaningful difference in patient care and safety.

About The Role

The Product Quality Assurance Engineer at ZOLL plays a vital role in maintaining and enhancing the quality of medical devices throughout their lifecycle. This hybrid position is based in Chelmsford, MA, and involves close collaboration with cross-functional teams such as Engineering, Manufacturing, Regulatory, and Post-Market services. The primary focus is on complaint investigations, risk management support, and product quality monitoring to ensure compliance with regulatory standards and internal quality systems. The role requires analyzing product performance data, supporting CAPA processes, and participating in design reviews to uphold the highest standards of patient safety and product reliability. The ideal candidate will be proactive in identifying quality issues, supporting continuous improvement initiatives, and ensuring thorough documentation of all quality activities.

Qualifications

• Bachelor's Degree in Engineering or a related technical discipline
• Minimum of 2 years of experience in quality engineering, product quality, or product engineering, preferably within a regulated industry
• Internship, co-op, or early career experience in medical devices, manufacturing, or a similar regulated environment
• Knowledge of quality system tools and data analysis techniques is a plus
• Familiarity with complaint handling, CAPA, nonconformance systems, and risk management processes
• Understanding of medical device design controls, verification and validation, and post-market quality activities
• Knowledge of FDA Quality System regulations, ISO 13485, or ISO 14971 standards is advantageous
• Advanced proficiency in English (written and verbal)

Responsibilities

• Assist with product and complaint investigations, including data collection, failure analysis, and root cause determination
• 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 and opportunities for quality improvements
• Participate in CAPA and nonconformance activities, ensuring proper documentation, tracking, and follow-up
• Contribute to product design reviews and quality assessments to ensure quality requirements are integrated throughout the product lifecycle
• Collaborate with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory, and Clinical teams to resolve product quality issues
• Support design verification and validation activities through review and participation in related quality processes
• Ensure all product quality activities comply with applicable regulatory requirements, standards, and internal procedures
• Maintain accurate, timely documentation of investigations, analyses, and quality records
• Participate in continuous improvement initiatives aimed at enhancing product quality, field performance, and quality system effectiveness

Benefits

• Competitive salary range of $82,400 to $90,000 annually, commensurate with experience and qualifications
• Comprehensive health, dental, and vision insurance plans
• Paid time off and holiday leave
• Retirement savings plans with company matching contributions
• Opportunities for professional development and career growth
• Inclusive and diverse work environment that values innovation and collaboration
• Flexible hybrid work arrangements to support work-life balance