Quality Assurance Engineer

Acute Care Technology At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service. At ZOLL, you won't just have a job. You'll have a career—and a purpose. Join our team. It's a great time to be a part of ZOLL! Due to the on‑site requirements of this position, applicants are expected to reside within a reasonable commuting distance of the designated work location (Chelmsford, MA). This role does not offer relocation. Job Type Hybrid Job Summary The Site Quality Assurance Engineer I supports manufacturing and operational quality activities, with a focus on investigations, quality data analysis, and process improvement. This role partners with Manufacturing, Operations, Supplier Quality, and Regulatory teams to support site quality processes and contribute to activities that ensure products meet regulatory requirements, company standards, and customer expectations. Essential Functions Support investigations related to manufacturing and operational quality issues, including data gathering, documentation, and follow-up actions. Analyze manufacturing quality data to identify trends, recurring issues, and opportunities for process and product quality improvement. Assist in nonconforming material investigations and Material Review Board activities, including documentation, disposition support, and coordination with cross-functional teams. Support process validation and equipment qualification activities through review of documentation, participation in quality assessments, and support of related quality processes. Participate in manufacturing process improvement initiatives to enhance product quality, process consistency, and quality system effectiveness. Assist with supplier quality investigations and corrective action activities to support timely resolution of supplier-related quality issues. Support internal audits, inspection readiness, and regulatory compliance activities to help ensure adherence to applicable quality system requirements and internal procedures. Partner with Manufacturing, Operations, Engineering, Supplier Quality, and Regulatory teams to support resolution of site quality issues and implementation of effective solutions. Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records. Contribute to continuous improvement initiatives related to manufacturing quality, process performance, and compliance. Required/Preferred Education and Experience Bachelor's Degree in Engineering or a related technical discipline 2+ years of relevant experience in quality engineering, manufacturing engineering, or a related quality or operations role, preferably in a regulated industry Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry Experience supporting supplier quality investigations or corrective action activities 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. Familiarity with root cause investigation tools and structured problem-solving methods. Strong organizational skills and attention to detail, with the ability to manage documentation and follow established processes. 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 FDA Quality System requirements, ISO 13485, and medical device regulatory requirements. Exposure to nonconformance management, MRB processes, process validation, or equipment qualification activities. Preferred Languages English - Advanced Travel Requirements Hybrid or on-site role with regular presence at a manufacturing or operational facility and occasional travel as needed for training, audits, investigations, or multi-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 Medical does not provide immigration-related sponsorship for this role. Do not apply for this role if you will need ZOLL immigration sponsorship (e.g. H1B, TN, STEM, OPT, etc.) either now or in the future. 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. The annual salary for this position is: $82,400.00 to $90,000.00 This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran. ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.