Job Description

Job Description

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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• An associate's degree in Quality, Regulatory Affairs, Engineering, Life Sciences, or a related field is required; a bachelor's degree is preferred.

• A minimum of 3 years' experience in document control, quality systems, or related roles within a regulated industry such as medical device, pharmaceuticals, biotechnology, or food safety.

• Strong working knowledge of ISO 9001, ISO 13485, FSSC 22000, and applicable regulatory requirements including FDA 21 CFR Part 820 requirements.

• Proficiency in using SharePoint is desired, as well as advanced skills in Microsoft Office applications including Word, Excel, and Outlook.

• Exceptional attention to detail maintaining data integrity, accuracy, and traceability in documentation processes.

• Strong verbal and written communication skills, with the ability to clearly explain document control processes and compliance expectations to cross-functional teams at all levels.

• Demonstrated ability to troubleshoot and resolve document control challenges, conduct root cause analyses, and implement corrective and preventative actions.

• Experience supporting internal and external audits, including ISO audits, FDA inspections, and third-party certification assessments. - Familiarity with MDSAP and EU MDR considered an asset

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