Product QA Engineer

About the Company

ZOLL Medical Corporation is a global leader in medical technology dedicated to improving patient outcomes and saving lives through innovative solutions. Our Acute Care Technology division develops and delivers lifesaving products and software to EMS, hospitals, public safety, and military organizations worldwide. We specialize in a wide range of medical devices including automated external defibrillators (AEDs), trauma kits, ventilators, and temperature management systems. Our commitment to excellence and innovation drives us to create reliable, high-quality solutions that make a meaningful difference in critical care settings. With a presence in over 140 countries, ZOLL fosters a culture of innovation, self-motivation, and entrepreneurial spirit, emphasizing continuous improvement and patient-centric care. Our dedicated employees take pride in their roles, contributing to a mission that impacts countless lives globally.

About the Role

The Product Quality Assurance Engineer at ZOLL plays a vital role in maintaining and enhancing the quality of our medical devices throughout their lifecycle. This hybrid position is based in Chelmsford, MA, and involves close collaboration with cross-functional teams including Engineering, Manufacturing, Regulatory, and Post-Market services. The primary focus of this role is to support complaint investigations, assist with risk management activities, and monitor product performance to ensure compliance with regulatory standards and internal quality systems. This role offers an exciting opportunity to be part of a mission-driven organization dedicated to advancing healthcare technology and making a tangible impact on patient outcomes.

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 data to identify trends, recurring issues, and opportunities for quality improvement
• Support CAPA and nonconformance processes, including documentation, tracking, and follow-up actions
• Participate in 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 Post-Market teams to resolve product quality issues
• Review documentation related to design verification and validation activities
• Ensure all product quality activities comply with applicable regulatory standards and internal procedures
• Maintain accurate and timely documentation of investigations, analyses, and quality records
• Contribute to continuous improvement initiatives to enhance product quality, reliability, and overall quality system effectiveness

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 regulated environment
• Familiarity with quality system tools and data analysis techniques is advantageous
• Knowledge of FDA Quality System Regulations (QSR), ISO 13485, or ISO 14971 is a plus
• Proficiency in English, with advanced communication skills

Benefits

• Competitive salary package within the range of $82,400 to $90,000 annually
• Comprehensive health, dental, and vision insurance plans
• Paid time off and holidays
• Retirement savings plans with company match
• Opportunities for professional development and career growth
• Collaborative and innovative work environment
• Hybrid work model with flexibility for remote work and on-site collaboration