Quality Assurance Compliance Specialist I
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 Summary
The Quality Assurance Compliance Specialist I supports the Quality Assurance Compliance team in maintaining compliance with global regulatory requirements and the Quality Management System (QMS). This role assists with CAPA activities, audit programs, quality system documentation, and regulatory compliance initiatives while developing foundational knowledge of medical device quality systems and regulations.
Essential Functions
- Support maintenance of the Quality Management System (QMS) in compliance with FDA (21 CFR Part 820), ISO 13485, EUMDR, and global regulatory requirements
- Assist with CAPA processes, including initiation, investigation support, tracking, and effectiveness verification
- Participate in internal audits and support external inspections (FDA, Notified Bodies, MDSAP) including audit readiness activities
- Assist with tracking, investigation, and closure of audit nonconformities
- Maintain quality documentation in accordance with Good Documentation Practices (GDP)
- Support regulatory compliance activities including:
- UDI data generation, verification, and maintenance (e.g., GUDID, EUDAMED)
- Product compliance and regulatory documentation support
- Assist with the training program by tracking training requirements and ensuring QMS compliance
Required/Preferred Education and Experience
- Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred
- Associate degree or technical certification with relevant experience may be considered
- 0-2 years of experience in a regulated industry (medical device, pharmaceutical, or biotech preferred)
- Internship, co-op, or academic exposure to quality systems strongly preferred
Knowledge, Skills and Abilities
- Familiarity with global medical device regulations (FDA QSR, ISO 13485, MDR, and/or MDSAP)
- Familiarity with CAPA, audits, nonconformance management, and Good Documentation Practices (GDP) preferred
- Strong attention to detail and data integrity mindset
- Effective written, verbal, and interpersonal communication skills
- Strong organizational, time management, and prioritization abilities
- Ability to work cross-functionally in a regulated environment
- Foundational understanding of FDA 21 CFR Part 820, ISO 13485, and quality system principles, preferred
- Experience with UDI systems and product regulatory compliance processes, preferred
- Experience with electronic Quality Management Systems (eQMS), preferred
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:
$60,000.00 to $70,000.00Factors 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.