Document Controller - ISO13485 - £27k - Oxford

Bond Williams ,
Oxford, Oxfordshire
Job Type: Full-time
Salary: £25,000 per annum

Overview

A Document Controller is required by a medical devices company in Oxford. As a Document Controller you will be responsible for coordinating Quality documentation. The Document Controller will be part of the QA/RA Team and will report directly to the Quality Manager. Major Responsibilities Under direction from the Quality Manager, the Document Controller will: Help the Operations department maintain documents and records related to manufacturing, including batch release, batch history records and device history records Work with Operations and Servicing to ensure procedures are compliant Help ensure all suppliers are approved and routinely evaluated in accordance with ISO 13485:2016 and 21 CFR Part 820 (other territories may apply) Work with the compliance manager to ensure device records are maintained correctly Help to ensure all Quality records are completed and stored in a timely manner Work with Operations to ensure any Supplier issues are recorded and investigated in a timely manner Work closely with Quality Manager to ensure close out and resolution of corrective actions Be part of the team to review and approve product for final release Be able to travel for audits and supplier visits, where required Skills and Experience The Document Controller will have: Working experience - ISO 13485:2016 A proven track record in working with quality systems The ability to work effectively in a multi-disciplinary team The ability to work with a wide range of projects simultaneously Ability to travel and be out of the country on a regular basis Qualifications Although not essential a degree in a science-related discipline is desirable Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency