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 procedures
• Review all incoming PCNs and assess for:
o Material changes
o Datasheet updates
• Route PCNs with relevant changes to designated product owners
• Maintain 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 Leadership
Quality 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 required
• Engineering/technical (electrical, mechanical) degree preferred.
• Experience using PLM systems and understanding of engineering change control workflow
Required 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 tool
• Excellent written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Solid knowledge and understanding of medical policies, procedures, and regulatory (e.g., medical, pharmaceutical) guidelines relevant to documentation
• Solid understanding of medical device documentation development activities
• Ability to manage confidential information with discretion
• Strict attention to detail
• Experience using PLM systems for change control (Windchill PLM STRONGLY preferred, TEAMCENTER preferred)
• Knowledge of CAD tools (CREO, AutoCAD, SolidWorks, Altium) a plus
• Ability to read engineering drawings and understand BOM/part structure
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Ability to work with minimal supervision to complete tasks
If 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