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…