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!
Job Type
Hybrid
Due to the on‑site (hybrid) 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.
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.
Job Summary
The Product Quality Assurance Engineer supports product quality throughout the product lifecycle, with a focus on complaint investigations, risk management support, and product quality monitoring. This role partners with Engineering, Manufacturing, Regulatory, and Post-Market teams to support investigations, analyze product performance, and contribute to activities that improve product reliability, patient safety, and compliance for medical devices.
Essential Functions
Assist with product and complaint investigations, including data gathering, product failure analysis, and support for root cause analysis activities.
Support product risk management activities, including documentation updates, risk assessments, and maintenance of risk management files in accordance with applicable standards and procedures.
Analyze complaint, service, and field performance data to identify trends, recurring issues, and opportunities for product quality improvement.
Support CAPA and nonconformance activities related to product quality issues, including documentation, tracking, and follow-up actions.
Participate in product design reviews and quality assessments to help ensure quality requirements are addressed throughout the product lifecycle.
Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams to support resolution of product quality issues.
Support design verification and validation quality activities through review of documentation and participation in related quality processes.
Ensure product quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures.
Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.
Contribute to continuous improvement initiatives related to product quality, field performance, and quality system effectiveness.
Required/Preferred Education and Experience
Bachelor's Degree in Engineering or a related technical discipline.
2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry.
Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry.
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.
Strong organizational skills and attention to detail, with the ability to manage documentation and follow established processes.
Ability to work collaboratively in a cross-functional team environment.
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 complaint handling, CAPA, nonconformance systems, or risk management processes.
Exposure to medical device design controls, verification and validation, or post-market quality activities.
Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971 is a plus
Preferred Languages
English - Advanced
Travel Requirements
Hybrid/Remote role with occasional travel as needed for team meetings, training, investigations, audits, or 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 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.
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The annual salary for this position is:
$82,400.00 to $90,000.00Factors 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 related technical discipline
- 2+ years of experience in quality engineering, product quality, or product engineering (preferably regulated industry)
- Internship, co-op, or early career experience in medical devices, manufacturing, or a regulated industry
- Familiarity with complaint handling, CAPA, nonconformance systems, and risk management processes
- Experience using quality system tools or data analysis tools
- Exposure to medical device design controls, verification and validation, or post-market quality activities
- Knowledge of FDA Quality System requirements, ISO 13485, or ISO 14971
- Basic understanding of engineering principles, data analysis, and problem-solving techniques
- Strong written and verbal communication and ability to work collaboratively in cross-functional teams
- Ability to work effectively in a hybrid/remote environment while collaborating across teams and time zones
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.
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