Remote Position with possible travel to Client APM HQ
No Overtime planned/required
Ensure appropriate and necessary documentation is in place to meet Client APM Quality System in compliance with regulatory requirements.
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 Client 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:
Material changes
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
Qualifications
Bachelor's Degree or equivalent and 5 years of previous related experience OR associate’s degree or equivalent and 7 years of previous related experience required
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
Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 45.18/hr.
