Quality Document Control Specialist

Title:

Quality Documentation Coordinator II Job Type:

Full-time, permanent Location:

Netherlands (Waalwijk) – On-site

Cpl Life Sciences is collaborating with a growing Medical Device Organisation who are looking to recruit 2x Documentation Coordinator II. These positions are on-site roles, so you must be located close to the site and hold the full right to work.

The Associate Documentation will work under the guidance of the Quality Assurance Manager to maintain the Document Control System to ensure control, security, integrity, and availability of documentation to site personnel. This person is responsible for implementing and maintaining document control and record retention for the site. This person is responsible for the control of documents and coordination of controlled document-related activity pursuant to GMP/ISO regulations.

Responsibilities: Maintain DHR documentation database. Control the flow of DHR documents to support lot release, as required. Create and update documentation for DHR files & logs. Filing and other organizational tasks. Perform Lot Release. Conduct internal quality audits, as required. Data input into the computer system. May provide guidance to other staff.

Education and Experience: Experience maintaining documents within a QC or GMP/ISO-certified environment preferred, or experience with Quality, Training or records management and/or equivalent combination of education and experience. Demonstrated knowledge of Microsoft Office, including Access. Knowledge of Microsoft Word. Knowledge of Configuration Data Management requirements for engineering documentation a plus but is not required. Working knowledge of documentation functions of a medical device company preferred. Familiarity with ERP (e.g., MFG/Pro) is a plus but is not required. Any Quality certifications a plus.

For more information, please contact lucy.kirkaldy@cpl.com