ZOLL Cardiac Management Solutions · 11 hours ago
Documentation Specialist
Chelmsford, MA
Full-time
Hybrid
Mid Level
$25.70/hr - $38.60/hr
3+ years expZOLL Cardiac Management Solutions is dedicated to improving patient outcomes through innovative technologies. The Documentation Specialist will support the Quality System Documentation and Change Control process related to ZOLL's Product Lifecycle Management System, ensuring proper documentation and collaboration with various departments.
Medical Device
Responsibilities
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
Qualification
Required
High School Graduate or equivalent required
3+ years' experience in Documentation Control required
Computer literate; experience with Microsoft Office (e.g. MS Word, MS Excel) and Adobe Acrobat (e.g. PDF)
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)
Preferred
Associate's Degree preferred
Working knowledge of Product Lifecycle Management systems and Oracle a plus
Benefits
Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.
Company
ZOLL Cardiac Management Solutions
ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes in cardiac patient care.
1001-5000 employees
H1B Sponsorship
ZOLL Cardiac Management Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase