Documentation Specialist II
ZOLL Cardiac Management Solutions is dedicated to improving patient outcomes through innovative technologies. The Documentation Specialist II will support the Quality System Documentation and Change Control process related to ZOLL's Product Lifecycle Management System, ensuring accurate documentation and coordination across departments.
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
Skills
- High School Graduate or equivalent required
- 1-3+ 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)
- Associate's Degree preferred
- Working knowledge of Product Lifecycle Management systems and Oracle a plus
Company Overview