Our client, a Medical Device Manufacturer, is looking to add a Document Control Specialist to their Pleasant Prairie, WI site. This individual will manage controlled documentation and support critical Quality Management System (QMS) functions within a highly regulated environment. This role is responsible for maintaining the integrity of the document control system, overseeing change control processes, and ensuring compliance with ISO 9001, ISO 13485, FSSC 22000, and applicable regulatory requirements including FDA 21 CFR Part 820. The Specialist will collaborate cross-functionally to ensure customer specifications are accurately incorporated into the ERP/QMS and to maintain audit and inspection-ready documentation. Additionally, this role will coordinate the completion of quality surveys and support continuous improvement initiatives across the organization.

Responsibilities:

- Follow all applicable safety policies while performing job duties.
- Administer the controlled documents library to ensure documents are current, properly approved, securely stored, and readily retrievable in compliance with applicable standards and regulatory requirements.
- Manage the document change processes, ensuring that revisions are appropriately initiated, reviewed, approved, implemented, and communicated to stakeholders.
- Maintain deviation tracking logs and associated documentation, ensuring timely investigation, closure and trend reporting for quality improvement initiatives.
- Support the maintenance and continuous improvement of the Quality Management System (QMS) through document control activities, compliance monitoring and process optimization.
- Prepare documentation and records to support internal audits, external audits, and regulatory inspections, ensuring audit and inspection-readiness.
- Collaborate with cross-functional teams, including Quality, Manufacturing, Engineering, Regulatory, and Supply Chain, to ensure documentation meets operational and regulatory requirements.
- Ensure all controlled documents meet ISO 9001, ISO 13485, FSSC 22000, FDA (21 CFR part 820), and applicable regulatory standards.
- Train internal teams on document control procedures, change management workflows, and regulatory compliance requirements to promote organizational adherence to quality standards.
- Develop and present reports and key performance indicators (KPIs) related to document control activities, audit findings, deviations and system effectiveness.
- Drive continuous improvement initiatives within document control and quality processes, identifying opportunities to enhance system performance, compliance and efficiency.

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