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 $90,000.00This 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.
Skills Required
- 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
- Experience in a regulated industry, preferably medical devices or manufacturing
- Experience supporting supplier quality investigations or corrective action activities
- 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
- Strong written and verbal communication skills
- Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements
- Exposure to nonconformance management, MRB processes, process validation, or equipment qualification
- Experience using quality system tools or data analysis tools
- Internship, co-op, or early-career experience in medical devices, manufacturing, or a regulated industry
- Advanced English proficiency
- Ability to reside within reasonable commuting distance of Chelmsford, Massachusetts
ZOLL Medical Corporation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ZOLL Medical Corporation and has not been reviewed or approved by ZOLL Medical Corporation.
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Healthcare Strength — Medical, dental, and vision coverage includes in‑network preventive care at 100% along with behavioral health/EAP and virtual therapy options. These features are often regarded as solid to good components of the package.
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Parental & Family Support — Paid parental leave provides 12 weeks at full pay for the birthing parent and 6 weeks for the non‑birthing parent after eligibility is met. This policy is frequently highlighted as a standout element.
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Wellbeing & Lifestyle Benefits — Wellness programs offer incentives and are complemented by multiple external well‑being recognitions. These programs add perceived value to total rewards.
ZOLL Medical Corporation Insights
What We Do
ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries.
