Document Control Team Leader

Kleboe Jardine Ltd
11 Jan 2018
10 Feb 2018
Contract Type
Full Time
My retained client, based in Dunfermline, is a high-profile business operating in the Medical Device market designing, developing and manufacturing products that offer early identification of health issues in patients. An exciting and challenging opportunity has arisen for a Document Control Team Leader to build a career in a stimulating industry, where the work you do will have a direct impact on people's health, ultimately saving sight and lives.

This role will be responsible for the management of the change cycle throughout the lifetime of product as well as ensuring the integrity of the Document and Change Control processes. Essentially, this role will manage the traceability of quality related documentation within the company's UK, US and European divisions. The role will also involve assigning and prioritising activities to support the product change processes throughout the team.

The company are looking for an effective leader to review the strategy of the process and make relevant changes to ensure the continual development and smooth running of the department.

Some further responsibilities are detailed below:

- Work cross functionally to manage and schedule change activities to ensure consistency of supply.
- Developing knowledge of the format of documentation and software for our quality system and to promote standardization and usage.

- Ensuring Quality System procedures are defined and followed.
- Assisting with the Management of Device Master Records, Device History Files including Engineering Change Orders, review minutes and validation protocol and reports.

- Support QA staff to assist engineers ensuring the correct templates or documents and procedures are used.
- Management of an accurate and structured filing system within Document and Change Control including historical data ensuring all items are logged and scanned where applicable and readily retrievable.
- Ensuring Device Master Record traceability is available and auditable through Change Plans and Engineering Change Orders.

The business has invested heavily in its staff, making this an excellent opportunity to grow a career.