Job Description
Job Description
A-Line Staffing is now hiring a Quality Document Sys Mgmt. The Quality Document Sys Mgmt experience would be working for a major company and has career growth potential.
If you are interested in this Quality Document Sys Mgmt position, please apply today for immediate consideration!
Quality Document Sys Mgmt Compensation :
- Pay Rate : 50.19 per hour
Quality Document Sys Mgmt Responsibilities :
Essential Job Functions
Evaluate changes proposed by initiators and provide feedback and recommendations for improvement and compliance.Lead special projects (e.g., Project PaRTy) in collaboration with team members; identify opportunities for change control process improvement including developing and proposing solutions and proposing new processes and system enhancements.Coordinate and perform incorporation of approved changes to documentation (e.g. JDE process sheets, drawings, PNs, technical summaries, etc.) per BD APM change control process in PLM and other applicable systems.Review change package against governing procedures and release final change package with increased complexity.Train / assist team members on engineering change control workflow (CR / CN) structure and proceduresReview all incoming PCNs and assess for :o Material changes
o Datasheet updates
Route PCNs with relevant changes to designated product ownersMaintain a tracking system for PCNs reviewed, routed, and approved.Collaborate with the Lifecycle Engineering team to refine triage criteria and improve efficiency.Ensure compliance with internal documentation and approval standards.Other duties as assigned by LeadershipQuality Document Sys Mgmt QUALIFICATIONS :
Qualifications
Bachelor's Degree or equivalent and 5 years of previous related experience OR associates degree or equivalent and 7 years of previous related experience requiredEngineering / technical (electrical, mechanical) degree preferred.Experience using PLM systems and understanding of engineering change control workflowRequired Skills
Good computer skills in usage of MS Office Suite (Excel, PowerPoint, Word, Visio, Project, etc.)Data analysis / reporting using Excel using VLOOKUP / pivot tables and / or powerBI or other analysis toolExcellent written and verbal communication skills and interpersonal relationship skillsGood problem-solving and critical thinking skillsSolid knowledge and understanding of medical policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentationSolid understanding of medical device documentation development activitiesAbility to manage confidential information with discretionStrict attention to detailExperience using PLM systems for change control (Windchill PLM STRONGLY preferred, TEAMCENTER preferred)Knowledge of CAD tools (CREO, AutoCAD, SolidWorks, Altium) a plusAbility to read engineering drawings and understand BOM / part structureAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast-paced environmentAbility to work with minimal supervision to complete tasksIf you think this Quality Document Sys Mgmt position is a good fit for you, please reach out to me - feel free to call, e-mail, or apply to this posting!
Heather Horkenbach
Staffing Manager
(586) 588-9799 Local
(877) 782-3334 Toll Free
(877) 782-3444 Fax
