hybrid Change Control Analyst

This hybrid Change Control Analyst role focuses on supporting Product Environmental Compliance (PEC) initiatives for medical instruments by leading change control and data retrieval/collection activities. Based in Kalamazoo, Michigan, the Specialist, Change Control & Data Retrieval/Collection will gather, validate, and integrate compliance data from internal systems and external suppliers to meet evolving regulatory requirements such as REACH, RoHS, PFAS, and PPWR. Responsibilities

• Lead structured data retrieval and collection efforts across internal systems such as PLM, ERP, and Quality Management Systems (QMS), as well as from external suppliers, to support PEC regulatory requirements.
• Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
• Partner cross-functionally with Engineering, Supply Chain, Regulatory, Quality, and external suppliers to obtain material, component, and product-level compliance data.
• Create and manage Enterprise Change Notices (ECNs) within the Quality Management System to implement updates tied to PEC findings, ensuring documentation and data inputs are compliant and audit-ready.
• Translate regulatory requirements into clear data needs by identifying required attributes, documentation, and evidence to support compliance initiatives.
• Support supplier engagement and outreach by requesting, tracking, and following up on material declarations, certifications, and compliance documentation.
• Perform data analysis and gap assessments to identify missing, inconsistent, or incomplete information and drive resolution with relevant stakeholders.
• Maintain and update project tracking tools and dashboards to provide visibility into data collection progress, risks, and completion status across PEC programs.
• Contribute to continuous improvement by standardizing data collection methods, templates, and workflows to enhance efficiency and scalability of PEC efforts.
• Act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.
• Build strong cross-functional relationships to gather, validate, and align data across global teams, suppliers, and systems.
• Proactively identify gaps in data availability, quality, and processes and recommend enhancements to data collection and reporting mechanisms.

Dashboard Templates Visionary Innovation Collections Scalability Supply Chain Traceability Communication Data Analysis Collaboration Schema Markup PTC Windchill Change Control Quick Learning Data Retrieval Detail Oriented Medical Devices Data Collection Change Management Data Availability Change Leadership Project Management Workflow Management Regulatory Compliance Artificial Intelligence Environmental Compliance Engineering Change Order Quality Management Systems Engineering Design Process Product Lifecycle Management Enterprise Resource Planning Continuous Improvement Process Enterprise Application Software Restriction Of Hazardous Substances Directive (ROHS) Compliance, * 1-3 years of experience in change management or change control, preferably involving engineering change orders or engineering change management.

• Strong attention to detail with the ability to manage, interpret, and validate complex datasets from multiple sources.
• Demonstrated ability to gather, analyze, and verify data across PLM, ERP, QMS, and other enterprise systems.
• Excellent communication skills, with the ability to collaborate effectively across diverse, global teams and external suppliers.
• Strong organizational and project management capabilities, including managing multiple data collection and change control activities concurrently.
• Ability to work in a fast-paced environment while maintaining high-quality, compliant outputs aligned with PEC requirements., * Preference for a Bachelor’s degree in Engineering or a related field, or higher-level education with an engineering mindset.
• Experience in change control or change management within a regulated industry.
• Experience in the medical device industry and familiarity with medical device quality systems.
• Familiarity with Product Environmental Compliance (PEC) regulations such as REACH, RoHS, and PFAS.
• Experience with PLM tools, such as Windchill or onePLM, or similar product lifecycle management systems.
• Experience working with supplier data collection, material declarations, certifications, and compliance documentation.
• Ability to quickly learn and apply PEC-related processes and tools through training and job shadowing.
• Comfort working with project tracking tools and dashboards to monitor progress and risks., Kalamazoo, MI*On-Site

AutoCAD Planning Research Budgeting Visionary Scheduling Innovation 3D Modeling Coordinating Communication Autodesk Revit Floor Planning Interior Design Project Management Project Coordination Organizational Skills Artificial Intelligence Construction Management Engineering Design Process SketchUp (3D Modeling Software) Mechanical Electrical And Plumbing (MEP) Systems +0

Google Project Management Change Control Analyst Actalent

Portage, MI*Remote

Auditing Dashboard Templates Visionary Innovation Collections Scalability Supply Chain Traceability Communication Data Analysis Collaboration Schema Markup PTC Windchill Change Control Quick Learning Data Retrieval Detail Oriented Medical Devices Data Collection Change Management Data Availability Change Leadership Project Management Workflow Management Regulatory Compliance Artificial Intelligence Environmental Compliance Engineering Change Order Quality Management Systems Engineering Design Process Product Lifecycle Management Enterprise Resource Planning Continuous Improvement Process Enterprise Application Software Restriction Of Hazardous Substances Directive (ROHS) Compliance

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