About this role
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
Responsible for supporting ZOLL's Quality System Documentation and the Change Control process (ECOs, ECRs, MCOs, and PDAs) activities related to the ZOLL's Product Lifecycle Management (PLM) System.
Essential Functions
- Generate and process Engineering Change Orders (ECOs), Engineering Change Requests (ECRs), Manufacturing Change Orders (MCOs), and Process Deviation Authorizations (PDAs) by incorporating input and effectively clarifying information from engineers or other sources.
- Create part and document numbers in Product Lifecycle Management (PLM) system to support assigned product lines.
- Follow departmental SOPs to ensure proper job-related procedures are followed.
- Identify project requirements by interviewing customers, analyzing operations, determining project scope, documenting results, and preparing ZOLL documentation in collaboration with project team.
- Serve as direct liaison to functional process owners to translate and prioritize requirements for their assigned projects.
- Ensure that all documents are issued correctly and have no filename errors.
- Responsible for Change Control activity by assigned Product Line.
- Accountable for coordinating with all departments of ZOLL to ensure proper records for PLM and Oracle Business systems.
- Work with Change Analyst Manager, PLM Administrator, and product line owners to ensure all tasks are completed on time.
- Work with the PLM Administrator to ensure that a maintained working knowledge base of PLM is up to date.
Required/Preferred Education and Experience
- High School Graduate or equivalent required
- Associate's Degree preferred
- 1-3+ years' experience in Documentation Control required
Knowledge, Skills and Abilities
- Computer literate; experience with Microsoft Office (e.g. MS Word, MS Excel) and Adobe Acrobat (e.g. PDF)
- Working knowledge of Product Lifecycle Management systems and Oracle a plus
- Self-starter with ability to work independently or as a member of a team
- Working knowledge of part numbering and bill of material (BOM) structuring
- Working understanding of FDA current good manufacturing practices (cGMP)
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 - Frequently
- 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'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.
#LI-LV1
The hourly rate for this position is:
$25.20 to $37.80Factors which may affect this rate include shift, 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.
Other facts
About ZOLL Medical Corporation
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. For more information, visit www.asahi-kasei.co.jp/asahi/en/.
What you'll do
- The Documentation Specialist II is responsible for supporting ZOLL's Quality System Documentation and Change Control process activities related to the Product Lifecycle Management System. This includes generating and processing Engineering Change Orders and ensuring proper documentation is issued correctly.
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