Job Description

Change Control

• Work with Quality Assurance Management and other departments in the generation, modification and processing of document changes within defined procedures, including changes associated with company projects such as new products, equipment and components

• Monitor the quality of new and revised documents for accuracy, clarity and compliance to internal and external standards

• Supports the cross-functional review and approval of document changes, including facilitating discussion, resolving change packet issues, and ensuring high quality review and participation by all members

• Understand how change affects Bill of Materials (BOMs) and provide input as applicable in the change control process

• Implement changes into Electronic Data Management System (i.e., Master Control and / or ERP systems)

• Coordinates the review and prioritization in the processing of change packets to ensure timely processing while maintaining high quality standards

• Recommend and implement changes or improvements to change control process

• Participate in product launch core teams by attending meetings, creating and maintaining QA deliverables such as Design Trees, X-revisions/Pre-Production, BOMs, and launch status updates

• Provide training, as required, on change control processes (e.g. change control, pre-production (X-Rev), etc.). Training may include inter/intra department class room / one-on-one training.

• Work with QA Management to develop metrics in the change packet process for the purposes of monitoring performance and reporting to departmental management

File Maintenance and Auditing

• Facilitate Quality Records archiving (scanning), where appropriate: including: manufacturing Device History Records (DHRs), Change Packets, Design History Files, Validations, Complaints and Receivers

• Maintain and audit document, change control and other QA department files, as well as associated electronic logs and databases per GMPs, Federal Regulations, International Standards, and company procedures

• Provide Corrective/Preventive Action Request responses and perform their associated follow up activities as it relates to document control Administration - daily work scheduling/planning

• Generate status reports and / or Management Operations Review reports

Education/Experience

• High school diploma or equivalent required. Bachelor degree in Business Administration, Management, or Management Science or equivalent work experience highly preferred.

• 5 years’ experience in documentation control systems required, with preference in coordination and administration of systems within a Medical Device Single Audit Program (MDSAP)/ISO and high-volume manufacturing work environment

• Demonstrated abilities and knowledge in document change management required

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