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Document Control Specialist
Employment Type:
Contract
Industry: Engineering, Light Industrial/Manufacturing, Professional/Administrative
Job Number: 61360
Office Location: Salem
Job Description
Our client, an innovative manufacturing facility working on cutting edge medical devices is seeking an experienced Document Control Specialist . You will work as part of a dynamic team that manufactures exciting products that help people. You will manage document control processes as well as other related quality systems. This role will report to the Quality Director and contributes as a critical facilitator between manufacturing, engineering, and project teams.
Qualifications:
- Bachelor’s or comparable experience
- 2+ years of experience working in a document control role supporting Quality and Engineering changes
- Experience working in a manufacturing company required
- Familiarity with GDP and working in the medical device field preferred
- Familiarity with ISO 9000 and/or ISO 13485 preferred
- Systems oriented with solid and demonstrable PLM and/or ERP experience
- Team player who prefers to take a collaborative approach in problem solving
- Organized, detail oriented, and self-directed; able to meet goals and deadlines without constant supervision
Responsibilities:
- You will be responsible for change control administration, part number management, Bill Of Materials and BOM structure, and applying revision.
- Ensure all changes are processed in a timely manner
- Coordinate weekly change board meetings to facilitate change review and closure
- Responsible for the proper organization, filing, archiving, and secure destruction of all controlled documents whether electronic or paper
- Ensure all change requests and documents within the Quality Management System are reviewed by the appropriate department
- Review change orders for accuracy, completeness, and impact to other documents, products, processes, and the PLM or ERP systems
- Regulate the change process so that only approved and validated changes are incorporated into released product documentation
- Provide Good Documentation Practices guidance to the team as needed
- Assist in all audits including FDA and Notified Bodies
- Proactively interface with internal and external customers to convey requirements, resolve issues, fulfill documentation requests, and otherwise facilitate the change process
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Techneeds has offered contract-to-hire and direct-hire talent solutions to some of the best employers in New England for over 45 years. As a Technology, Manufacturing, and Engineering staffing & recruitment agency, we’re experts at finding, screening, and placing in-demand talent with top employers in New England.
Job Requirements
Document control, BOM's, Drawings
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