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
Remote
Job Summary
The Senior Product Quality Assurance Engineer provides technical leadership for product quality throughout the product lifecycle, with a strong focus on field performance, risk management, and continuous improvement. This role leads complex investigations, partners cross-functionally with Engineering, Manufacturing, Regulatory, and Post-Market teams, and drives actions that improve product reliability, patient safety, and compliance for medical devices.
Essential Functions
- Lead complex product and field failure investigations, including root cause analysis, data trending, and corrective action development.
- Drive product reliability and quality improvements across the product lifecycle, from development through post-market support.
- Lead and support risk management activities, including risk assessments, hazard analysis, and risk file updates in accordance with applicable standards and procedures.
- Partner with Design Assurance, R&D, Manufacturing, Supplier Quality, Regulatory Affairs, and Clinical/Post-Market teams to resolve quality issues and implement robust solutions.
- Support design verification and validation activities by providing quality oversight, reviewing protocols and reports, and ensuring compliance with internal and external requirements.
- Analyze complaint, service, and field performance data to identify trends, emerging risks, and opportunities for corrective and preventive action.
- Lead or support nonconformance, CAPA, and escalation activities related to product quality issues.
- Ensure product quality activities comply with applicable regulatory requirements, quality system standards, and internal procedures.
- Provide mentorship to engineers and team members, and help shape product quality strategies, best practices, and investigation approaches.
- Contribute to inspection readiness and support internal, customer, and regulatory audits as needed.
Required/Preferred Education and Experience
- Bachelor's Degree in Engineering or a related technical discipline
- 7-12 years of experience in product quality, quality assurance, or quality engineering, preferably in the medical device industry
- ASQ Certified Quality Engineer or similar certification is a plus
Knowledge, Skills and Abilities
- Demonstrated experience leading complex investigations, root cause analysis, and product quality improvement initiatives.
- Strong knowledge of risk management principles and product lifecycle quality processes.
- Experience working in cross-functional environments to resolve technical and quality issues.
- Strong written and verbal communication skills, with the ability to present findings and recommendations clearly to technical and non-technical stakeholders.
- Ability to work independently in a remote environment while effectively collaborating across teams and time zones.
- Experience in medical device design controls, verification and validation, and post-market quality.
- Familiarity with CAPA, complaint handling, nonconformance systems, and field performance monitoring.
- Knowledge of FDA Quality System requirements, ISO 13485, and risk management standards such as ISO 14971.
- Experience mentoring junior engineers or leading technical quality efforts.
Preferred Languages
- English - Advanced
Travel Requirements
- Remote role with travel as needed for team meetings, 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.
The annual salary for this position is:
$119,100.00 to $178,600.00This 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.
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
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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.
