Associate Change Control & Data Retrieval Specialist

System One, Inc.; Portage (MI); Hybride; USD 48 000 - 68 000; Temps partiel

Résumé du poste

System One, Inc. is seeking an Associate Change Control & Data Retrieval Specialist in Portage, MI. This contract role combines hybrid work arrangements with onsite and remote duties to support PEC regulatory requirements and data-driven compliance initiatives.

You will lead data retrieval across PLM/ERP/QMS, validate complex datasets, and coordinate with Engineering, Supply Chain, Regulatory, and Quality teams. Experience with PEC regulations and PLM tools is preferred.

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• Strong attention to detail and ability to manage complex datasets.
• Experience gathering, analyzing, and validating data from multiple sources.
• Excellent communication and collaboration across global teams.

Responsabilités

• Lead data retrieval across internal systems (PLM, ERP, QMS) and external sources to support PEC regulatory requirements.
• Compile, cleanse, and validate datasets for regulatory submissions and internal reporting.
• Create and manage ECNs within the Quality Management System to implement PEC findings.
• Translate regulatory requirements into data needs and evidence.
• Support supplier engagement to obtain material declarations and compliance docs.
• Maintain and update project tracking tools and dashboards for PEC programs.

Connaissances

Attention to detail

Data analysis

Cross-functional collaboration

Regulatory knowledge

Project management

Communication

Formation

Bachelor's degree in Engineering or related field

Outils

Windchill / onePLM

PLM tools

Description du poste

Job Title: Associate Change Control & Data Retrieval Specialist
Location: Portage, MI
Type: Contract
Compensation: $42/hr
Work Model: Hybrid- onsite and remote

Responsibilities

• 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.

Requirements

• 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

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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