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
This individual will drive Quality Improvements through the Corrective and Preventative Action program in a cross functional environment. Support the Organizations Internal Audit program and participate in external audits to ensure we maintain regulatory compliance. Assist with content review for Quality System documents and regulatory communication.
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.
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.
Essential Functions
- Review CAPA(s) for appropriate content Monitor and Manage CAPA KPl(s) to objectives
- Ability to lead a cross-functional team through CAPA
- Maintain and look for opportunities to continuously improve the CAPA process and compliance to all applicable regulations
- Conduct appraisals program yearly or as needed for CAPA Leads Assist in the development, training and expectation for CAPA Leads Assist in the management and scheduling for Internal Auditing Ensure internal audit finding response time meets internal targets Ensure timely closure of internal audit responses
- Participate in external audits related to manufacturing site under QMS umbrella Ensure timely QS compliance related to SOP review
- Assist in the review of Health Risk Assessment's
- Assist in the development and review of Competent Authority, Registrar and Regulatory Agency correspondence
- Support managers and supervisors to define training requirements and ensure employees are trained to adequately perform their assigned responsibilities related to the Quality Management System.
Required/Preferred Education and Experience
- Four-year degree required
- Minimum 5 years related experience in a regulated environment, preferably Medical Device Industry preferred
Knowledge, Skills and Abilities
- Excellent written, verbal and interpersonal communication skills Proficient time management and project management skills
- Experience with FDA QSR, ISO13485, MDD and MDR, MDSAP and ISO14971 for Medical Devices
- Proficient with auditing techniques
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's 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:
$90,000.00 to $110,000.00Factors 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
- Four-year degree
- Minimum five years of related experience in a regulated environment
- Experience in the medical device industry
- Experience with FDA QSR, ISO 13485, MDD, MDR, MDSAP, and ISO 14971 for medical devices
- Proficiency with auditing techniques
- Strong written, verbal, and interpersonal communication skills
- Proficient time management and project management skills
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.
