×
Register Here to Apply for Jobs or Post Jobs. X

US-RD

Job in North Bothell Area, Snohomish County, Washington, 98021, USA
Listing for: LanceSoft Inc
Contract position
Listed on 2026-07-09
Job specializations:
  • Engineering
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 72.25 USD Hourly USD 72.25 HOUR
Job Description & How to Apply Below
Below is the Job Details for your reference:
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
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
 
 
 
Search for further Jobs Here:
(Try combinations for better Results! Or enter less keywords for broader Results)
Location
Increase/decrease your Search Radius (miles)
0
200
Filters
Education Level
Experience Level (years)
Posted in last:
Salary