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This role is responsible for ensuring the site’s GMP Document and Records Management process is followed within the document management system, including electronic documents and records. This includes supporting site functions to maintain clear, accurate, and compliant Quality Management procedures. This role ensures all documentation aligns with regulatory standards, internal quality systems, and customer requirements.

• This position requires solid understanding of the document control lifecycle within the medical device/IVD industry, including management of paper and electronic documents and records including, approval, versioning, distribution, archiving, obsolescence, metric tracking, and training delivery.
• Maintain a variety of technical documents within the Quality System including:
• Standard operating procedures (SOPs)
• Work Instructions
• Associated GMP record
• Troubleshoot issues within the electronic document management system, ensuring document accuracy and alignment with processes
• Ensure documentation complies with applicable regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR)
• Provide training, support and guidance to organization as needed
• Serve as the document control representative on projects and global teams
• Maintain controlled documents in document management systems (approval, versioning, distribution, archiving, obsolescence)
• Revise documents for both technical and non-technical audiences, adapting content to meet user needs and regulatory requirements
• Performs and/or supports internal and/or external audits as required
• Performs other related duties and projects as business needs require at direction of management
• Perform records management duties as needed
• Perform data collection and analysis to create and maintain quality metrics for review, identification, and escalation of document and records control trends and areas of improvement.

• This position requires solid understanding of the document control lifecycle within the medical device/IVD industry, including management of paper and electronic documents and records including, approval, versioning, distribution, archiving, obsolescence, metric tracking, and training delivery.
• Maintain a variety of technical documents within the Quality System including:
• Standard operating procedures (SOPs)
• Work Instructions
• Associated GMP record
• Troubleshoot issues within the electronic document management system, ensuring document accuracy and alignment with processes
• Ensure documentation complies with applicable regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, MDR, IVDR)
• Provide training, support and guidance to organization as needed
• Serve as the document control representative on projects and global teams
• Maintain controlled documents in document management systems (approval, versioning, distribution, archiving, obsolescence)
• Revise documents for both technical and non-technical audiences, adapting content to meet user needs and regulatory requirements
• Performs and/or supports internal and/or external audits as required
• Performs other related duties and projects as business needs require at direction of management
• Perform records management duties as needed
• Perform data collection and analysis to create and maintain quality metrics for review, identification, and escalation of document and records control trends and areas of improvement