What are the responsibilities and job description for the Associate Engineer, PEC position at GForce Life Sciences?
6-month Contract
Hybrid in Portage, MI
Must be able to work on a W2
Key Responsibilities (what You’ll Do)
Hybrid in Portage, MI
Must be able to work on a W2
Key Responsibilities (what You’ll Do)
- Retrieve and collect compliance-related data from internal systems (e.g., PLM, ERP, QMS) and external sources (e.g., suppliers).
- Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and submission readiness.
- Partner cross-functionally with Engineering, Supply Chain, Regulatory, Quality, and external suppliers to obtain material/component/product compliance information.
- Create and manage Enterprise Change Notices (ECNs) within the Quality Management System to implement PEC-driven updates and maintain audit-ready documentation.
- Translate regulatory requirements into actionable data needs (attributes, documentation, and supporting evidence).
- Conduct gap assessments to identify missing/inconsistent information and drive resolution with stakeholders.
- Maintain project tracking tools and dashboards to provide visibility into progress, risks, and completion status.
- Improve processes by standardizing data collection methods, templates, and workflows.
- Bachelor’s degree in Engineering or related field
- Strong attention to detail and ability to manage/interpret complex datasets
- Experience gathering, analyzing, and validating data from multiple sources
- Strong communication and collaboration skills across diverse, global teams
- Strong organizational and project management capabilities
- Change control/change management experience in a regulated industry
- Medical device industry experience
- Familiarity with PEC regulations (e.g., REACH, RoHS, PFAS)
- Experience with PLM tools (e.g., Windchill/onePLM) or similar systems
- Experience working with supplier data collection and compliance documentation