Acute Care TechnologyAt 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 TypeRemote
Job SummaryThe 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 LanguagesTravel Requirements- Remote role with travel as needed for team meetings, investigations, audits, or site support
Physical DemandsThe 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 $178,600.00
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.