Documentation Control Specialist
Weston, MA 01778
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Title: Documentation Control Specialist
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration: Perm
- Pay rate: $60k
- Job Location: Weston, MA
- Job#: bh 13763
Documentation Control Specialist
The QA Document Control Specialist will interface closely with other cross-functional groups such as Operations, Facilities, Engineering, Regulatory, and Marketing and act as a direct liaison between these departments and the Quality function.
Essential Job Functions
- Manage document workflows in the electronic PLM system (Agile).
- Ensure documents maintain a controlled lifecycle in accordance with established procedures.
- Identify change order issues and provide resolution options.
- Ensure documents meet formatting and template requirements and adhere to required review and approval requirements as well as project timelines.
- Schedule and lead cross functional meetings, issuing meeting minutes, and following up on action items.
- Update Document Control procedures and training material.
- Perform document periodic review process. Track, monitor, and work with owners per defined schedule.
- Oversee the issuance and maintenance of lab notebooks.
- Provide documentation support during audits and regulatory inspections.
- Complete work assignments independently or with minimal supervision.
- Storage, retrieval, updating, and reproduction of Engineering, Manufacturing and Quality documentation for the business. This includes all offsite documentation storage activities.
- Provide quality documentation support and guidance to all business functions.
- Provide Document Control metrics, as required by management.
- Collaborate with all departments to coordinate the distribution and approval of changes.
- Effectively communicate with all levels of the organization.
- Train business staff in the proper usage of the Agile system regarding change orders, part numbers and file searches, as well as providing day to day support to the active users of the Agile system.
- Identify and recommend Document Control process and procedural improvements.
- Minimum, High School diploma
- 1-3 years relevant experience in a regulated industry
- Working knowledge of electronic documentation control or PLM system. Familiarity with ERP is beneficial, but is not required (Agile and Oracle systems preferred, but not required)
- Familiarity with ISO 13485, CFR Part 820, and MDR standards and regulations preferred
- Proficient in Microsoft Office
- Working knowledge of documentation functions of a medical device company
- Must be highly motivated and willing to learn
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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