Change Control & Data Retrieval/Collection Specialist

IntePros

Portage (MI)

Hybrid

USD 65,000 - 90,000

Full time

23 hours ago
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Job summary

Intepros is seeking a Specialist, Change Control & Data Retrieval/Collection to support product environmental compliance in a regulated medical device environment. Hybrid role in Kalamazoo, MI, focusing on data collection from PLM/ERP/QMS, ECN management, and collaboration across engineering, regulatory, quality, and supply chain.

Strong data skills and knowledge of PEC regulations preferred. The role emphasizes data integrity, audit readiness, and continuous improvement of data processes and

Qualifications

  • Bachelor’s degree in engineering or related field required.
  • Strong attention to detail and ability to manage complex datasets.
  • Experience gathering, analyzing, and validating data from multiple sources.
  • Excellent communication and collaboration with cross-functional, global teams.
  • Solid organizational and project management skills.

Responsibilities

  • Retrieve and collect data from internal systems (PLM, ERP, QMS) and external suppliers to support regulatory requirements.
  • Compile, clean, and validate complex datasets for accuracy and compliance readiness.
  • Collaborate with Engineering, Supply Chain, Regulatory, Quality, and suppliers for data.
  • Create and manage ECNs within a QMS, ensuring audit-ready documentation.
  • Translate regulatory requirements into data collection needs and evidence.
  • Coordinate supplier outreach and track material declarations and compliance docs.
  • Perform data gap assessments, resolve inconsistencies, and track project progress.
  • Maintain project dashboards and identify data process improvements.
  • Support change implementation plans with regulatory timelines.

Skills

Attention to detail
Data analysis
Cross-functional collaboration
Project management

Education

Bachelor’s degree in Engineering or related field

Tools

Windchill
onePLM
QMS

Job description

Location: Kalamazoo, MI

Work Arrangement: Hybrid

Field: Engineering

We’re actively seeking qualified candidates for a Specialist, Change Control & Data Retrieval/Collection to support product environmental compliance initiatives within a regulated medical device environment.

What You’ll Do
  • Retrieve and collect data from internal systems (PLM, ERP, QMS) and external suppliers to support regulatory requirements, including REACH, RoHS, PFAS, and PPWR.
  • Compile, clean, and validate complex datasets to ensure accuracy, traceability, and compliance readiness.
  • Collaborate with Engineering, Supply Chain, Regulatory, Quality, and suppliers to obtain material, component, and product compliance data.
  • Create and manage Enterprise Change Notices (ECNs) within a Quality Management System (QMS), ensuring documentation is accurate and audit-ready.
  • Translate regulatory requirements into data collection needs, documentation, and supporting evidence.
  • Coordinate supplier outreach and track material declarations, certifications, and compliance documentation.
  • Perform data gap assessments, resolve inconsistencies, and track project progress, risks, and completion status.
  • Maintain project dashboards and tracking tools while identifying opportunities to improve data collection processes and workflows.
  • Support change implementation plans and ensure alignment with regulatory timelines.
Required Qualifications
  • Bachelor’s degree in Engineering or a related field.
  • Strong attention to detail and the ability to manage and interpret complex datasets.
  • Experience gathering, analyzing, and validating data from multiple sources.
  • Excellent communication and collaboration skills when working with cross-functional and global teams.
  • Strong organizational and project management skills.
Preferred Qualifications
  • Experience with change control or change management in a regulated industry.
  • Medical device industry experience.
  • Familiarity with Product Environmental Compliance (PEC) regulations, including REACH, RoHS, and PFAS.
  • Experience with PLM systems such as Windchill or onePLM, or similar platforms.
  • Experience with supplier data collection and regulatory compliance documentation.
Who Will Succeed in This Role?

We’re looking for a detail-oriented, collaborative professional who can navigate complex data systems, identify information gaps, coordinate across global teams, and help ensure environmental compliance requirements are met accurately and efficiently.

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