|Job Title:||Documentation Controller|
|Duration:||Fixed Term Contracts|
|Contact Name:||David Walsh|
We are currently recruiting for the position of a Documentation Controller on a fixed-term contract.
Functional Area: Quality
Career Framework Title: Quality Administrator 3
Internal Job Title: Documentation Controller
Job Level: 06
This position is responsible for the administration of the electronic Document Management system, in line with Corporate policies and the company's quality system procedures, including audits. This position will report to the Quality Manager.
- Liaises with Customers on all documentation issues.
- Co-ordination of the Change Management Process.
- Issues new and revised quality system documentation efficiently and ensure that the most current revisions are made available to all users and change records are completed correctly so as to maintain the quality system.
- Monitoring of the approval process for documents and notification to approvers of document readiness through an electronic DMS.
- Carries out documentation audits in accordance with the internal audit schedule or production priorities.
- Record and trend all documentation deficiencies, errors, etc. and provide these reports weekly to Quality Systems Engineer.
- Provides training when needed, to personnel on the essential elements of the electronic documentation system.
- Responds to all queries in a timely manner with accurate and complete information.
- BAAN engineering data management, revision control, and BOM control.
- Reviews associated production line documentation such as logbooks, in-process check sheets, etc.
- Maintains systems in place to remove and control obsolete quality system documents.
- Maintains and update an orderly filing, archiving and retrieval system for:
- Devise Master and History documents, Drawings, Logs in the area, e.g. change request log.
- Supports Quality Systems Engineer in preparation for notified or customer audits.
- Record retention co-ordination. Responsible for the coordination, tracking, and storage of records relevant to the Department/Function, as per Celestica Records Management Program Operating Procedure
- Ability to work independently and as a member of a team in a dynamic environment.
- Good communication/team skills to interface with internal customers at all levels.
- Good knowledge of all Microsoft Office applications and the ability to operate local quality DBMS systems.
- Excellent knowledge of ISO 13485 and 21 CFR 820 is essential.
- Strong knowledge of NPI/ECO activity essential
- Strong attention to detail and organization skills.
- Good presentation skills to conduct training and presentations.
- 2-3 years’ experience in a similar role.
- Second Level Qualification or equivalent or experience in a quality systems administration area.
- Experience in working in a medical device environment would be a distinct advantage
- Knowledge of Quality Management Systems desirable
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