Change Control Engineer

JBL Resources

Portage (MI)

On-site

USD 70,000 - 100,000

Full time

13 days ago

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Job summary

JBL Resources is seeking a Change Control Engineer in Kalamazoo, MI to drive data-driven regulatory compliance across PEC programs. You will lead data collection from PLM/ERP/QMS, coordinate with suppliers and cross-functional teams, and manage ECNs to ensure audit-ready documentation.

The role focuses on translating regulatory requirements into data needs, performing gap analyses, and improving data collection processes to support timely regulatory submissions and internal reporting.

Qualifications

  • Bachelor’s degree in Engineering or related field.
  • Ability to gather, analyze, and validate data from multiple sources.
  • Strong attention to detail when managing and interpreting complex datasets.
  • Excellent communication and collaboration skills across cross-functional teams.
  • Strong organizational and project management capabilities.
  • Experience with change control or change management in regulated industry.
  • Medical device industry experience.
  • Familiarity with Product Environmental Compliance regulations, such as REACH, RoHS, or PFAS.
  • Experience with PLM tools such as Windchill or onePLM.
  • Experience collecting supplier data and managing compliance documentation.

Responsibilities

  • Lead data retrieval across internal systems and external suppliers to support PEC regulatory requirements.
  • Compile, cleanse, and validate complex datasets for regulatory submissions and internal reporting.
  • Partner cross-functionally to obtain material, component, and product-level compliance data.
  • Create and manage ECNs within the Quality Management System to implement PEC updates.
  • Translate regulatory requirements into data needs and evidence to support compliance initiatives.
  • Support supplier engagement and documentation collection for declarations and certifications.
  • Perform data analysis and gap assessments; drive resolution with stakeholders.
  • Maintain project tracking tools and dashboards for PEC programs.
  • Standardize data collection methods and workflows to improve efficiency and scalability.
  • Act as Change Owner as needed and coordinate implementation plans.

Skills

Data analysis
Attention to detail
Communication
Project management
Change control
Regulatory knowledge
Medical device experience
Regulatory compliance
Supplier data

Education

Bachelor’s degree in Engineering

Tools

Windchill
onePLM

Job description

Change Control Engineer Location: Kalamazoo, Michigan

About Our Client: Our client has built a high-trust, people-first culture driven by real employee feedback and a commitment to innovation, collaboration, and performance. Known for fostering an environment where employees feel valued, supported, and empowered to grow, the organization continues to set itself apart as an employer of choice. Working here means joining a team of top technical professionals bringing cutting-edge products to the forefront—offering driven individuals the opportunity to make a meaningful impact every day.

Key Responsibilities:
  • Leading 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).
  • Compiling, cleansing, and validating complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting.
  • Partnering cross-functionally with Engineering, Supply Chain, Regulatory, Quality, and external suppliers to obtain required material, component, and product-level compliance data.
  • Creating and managing Enterprise Change Notices (ECNs) within the Quality Management System to implement updates tied to PEC findings while ensuring all documentation and data inputs are compliant and audit-ready.
  • Translating regulatory requirements into data needs and identifying required attributes, documentation, and evidence to support compliance initiatives.
  • Supporting supplier engagement and outreach by requesting, tracking, and following up on material declarations, certifications, and compliance documentation.
  • Performing data analysis and gap assessments, highlighting missing or inconsistent information, and driving resolution with stakeholders.
  • Maintaining and updating project tracking tools and dashboards to ensure visibility into data collection progress, risks, and completion status across PEC programs.
  • Contributing to process improvements by standardizing data collection methods, templates, and workflows to enhance the efficiency and scalability of PEC efforts.
  • Acting as Change Owner as needed, coordinating implementation plans, and ensuring execution aligns with regulatory timelines.
Qualifications:
  • Bachelor’s degree in Engineering or a related field.
  • Ability to gather, analyze, and validate data from multiple sources.
  • Strong attention to detail when managing and interpreting complex datasets.
  • Excellent communication and collaboration skills across cross-functional teams.
  • Strong organizational and project management capabilities.
  • Experience with change control or change management in a regulated industry.
  • Medical device industry experience.
  • Familiarity with Product Environmental Compliance regulations, such as REACH, RoHS, or PFAS.
  • Experience with PLM tools such as Windchill or onePLM.
  • Experience collecting supplier data and managing compliance documentation.

NO C2C CANDIDATES

JBL is an Equal Opportunity Employer and E-Verify Company

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