US-RD

Support internal and external audits by: Providing traceability reports (MLO/DHF/DMR), demonstrating control over Windchill processes and data, and addressing audit findings and supporting corrective/preventive actions (CAPA) related to PLM processes. • Multi-Office Coordination: Serve as part of a centralized PSO function supporting multiple geographic or functional offices.

Below is the Job Details for your reference:
  RoleSystems Specialist - PTC Windchill / Change ManagerLocationBothell, WA, 98021Pay Range$72.25/Hr. On W2 (Without Benefits) Duration6 months (contract to hire)  
JOB DESCRIPTION:
 
Job Responsibilities:
 
•            Windchill PLM Administration (Regulated Environment): Manage user roles, permissions, and security to ensure proper data access and segregation of duties.
•            Administer and maintain Windchill business objects, including:
 
o            Master List Objects (MLOs)
o            Change Requests (CR), Change Notices (CN), and Problem Reports
o            Controlled documents (design documents, specifications, procedures)
o            CAD-related objects
o            Parts (EBOM/MBOM structures)
 
•            Maintain Windchill containers (Products, Libraries, Projects).
•            Support creation, maintenance, and audit readiness of:
 
o            Design History File (DHF) within Windchill (ensuring completeness, traceability, and proper structure).
o            Device Master Record (DMR) by maintaining controlled product definitions, specifications, and released records.
 
•            Ensure all controlled documents: Follow approved templates, include required metadata (classification, ownership, approvals), and are version-controlled and properly released.
•            Support internal and external audits by: Providing traceability reports (MLO/DHF/DMR), demonstrating control over Windchill processes and data, and addressing audit findings and supporting corrective/preventive actions (CAPA) related to PLM processes.
•            Multi-Office Coordination: Serve as part of a centralized PSO function supporting multiple geographic or functional offices.
•            Collaborate with Program/Project Management, Engineering, Quality Assurance, and other relevant internal stakeholders.
•            Support system enhancements, upgrades, and validation activities.
•            Participate in continuous improvement initiatives for PLM processes and quality system integration.
•            Facilitate communication between central PMO and local project teams.
 
Required Qualifications:
 
•            Education: Bachelor's degree (or equivalent experience) in Project Management, Engineering, Information Systems, or a related field.
•            Experience: 3-5 years of experience administering or supporting Windchill PLM in a regulated environment. Experience supporting cross-functional teams in a quality-driven environment.
•            Required Knowledge: Strong understanding of design control processes, document control systems, and engineering change management.
•            Technical Skills: Proficiency with Microsoft Office tools.
 
Preferred Qualifications:
 
•            Experience in the medical device or highly regulated industry.
•            Experience supporting MLO/DHF/DMR structures in PLM systems.
•            Knowledge of Windchill configuration, workflows, and lifecycle management.
•            Experience with PLM-ERP integrations (e.G., SAP) and CAD integrations.
•            Background in audit support and regulatory inspections.
 
Key Skills & Competencies:
 
•            Windchill PLM administration in a regulated environment
•            Design control and configuration management
•            Data integrity and compliance (ALCOA+ principles)
•            Document control and change management
•            Audit readiness and regulatory support
•            Strong attention to detail and data accuracy
•            Strong organizational and coordination skills
•            Cross-functional communication and stakeholder management
•            Problem-solving and root cause analysis
•            Process-oriented mindset with continuous improvement focus
•            Process documentation and training delivery