More jobs:
US-RD
Job in
North Bothell Area, Snohomish County, Washington, 98021, USA
Listed on 2026-07-09
Listing for:
LanceSoft Inc
Contract
position Listed on 2026-07-09
Job specializations:
-
Engineering
Regulatory Compliance Specialist
Job Description & How to Apply Below
Role Systems Specialist - PTC Windchill / Change Manager Location Bothell, WA, 98021 Pay Range $72.25/Hr. on W2 (Without Benefits) Duration 6 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
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