Specialist, Control & Data Retrieval​/Collection

Specialist, Change Control & Data Retrieval/Collection

Company is seeking to hire a Specialist, Change Control & Data Retrieval/Collection to support the Instruments Product Environmental Compliance (PEC) PMO portfolio. This hybrid role is based in Kalamazoo, Michigan.

Who We Want

• Collaborative partners:
  Individuals who build strong cross-functional relationships to gather, validate, and align data across global teams, suppliers, and systems.
• Detail-oriented problem solvers:
  Professionals who can navigate complex datasets, trace information across multiple systems, and ensure accuracy and completeness for regulatory compliance.
• Goal-oriented achievers:
  Individuals who thrive in fast-paced environments and are focused on delivering compliant, high-quality outputs aligned to evolving PEC requirements.
• Continuous improvement drivers:
  People who proactively identify gaps in data availability, quality, and processes, and work to enhance data collection and reporting mechanisms.

What You Will Do

• Lead data retrieval and collection efforts across internal systems (e.g., PLM, ERP, QMS) and external sources (e.g., suppliers) to support PEC regulatory requirements (e.g., REACH, RoHS, PFAS, PPWR).
• Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
• Partner cross-functionally (Engineering, Supply Chain, Regulatory, Quality, and external suppliers) to obtain required 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 all documentation and data inputs are compliant and audit-ready.
• Translate regulatory requirements into data needs, identifying required attributes, documentation, and evidence to support compliance initiatives.
• Support supplier engagement and outreach to request, track, and follow up on material declarations, certifications, and compliance documentation.
• Perform data analysis and gap assessments, highlighting missing or inconsistent information and driving resolution with stakeholders.
• Maintain and update project tracking tools and dashboards, ensuring visibility to data collection progress, risks, and completion status across PEC programs.
• Contribute to process improvements by standardizing data collection methods, templates, and workflows to enhance efficiency and scalability of PEC efforts.
• May act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.

What You Need

• Required:
• Bachelor's degree in Engineering or related field
• Strong attention to detail with the ability to manage and interpret complex datasets
• Demonstrated ability to gather, analyze, and validate data from multiple sources
• Excellent communication and collaboration skills across diverse, global teams
• Strong organizational and project management capabilities
• Preferred:
• Experience in change control or change management within a regulated industry
• Experience in the medical device industry
• Familiarity with Product Environmental Compliance (PEC) regulations (e.g., REACH, RoHS, PFAS)
• Experience with PLM tools (Windchill/onePLM) or similar systems
• Experience working with supplier data collection and compliance documentation

Work schedule:

• Hybrid position, initial training will require more onsite time but hybrid schedule will be set based on contingent performance (typically 2-4 days onsite weekly)
• Working Eastern Time Zone hours
• Some flexibility with 8 or 9 start time
• Possibility for OT but typically 40 hours weekly
• Targeting 8/10 start date

Must haves:

• Candidate must be adaptable (working in an ever-changing environment) and have ability to take initiative
• Candidate must have strong communication and collaboration skills, will be working with internal company teams
• Candidate must have strong time management skills and ability to make decisions on how they work independently