US-RD

Below is the Job Details for your reference: 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