Document Control Supervisor - Medical Devices

Smiths Medical
Not specified
15 Apr 2018
20 Apr 2018
Contract Type
Full Time
Smiths Medical in Ashford is seeking an experienced Document Control Supervisor to join the company on a permanent basis. The role will be responsible for supervising the day to day activities of a team of Document Control Coordinators, as well as execute hands-on document control and document change management activities. This is a great opportunity to join a leading global medical devices company in a role with an international focus and a number of potential development routes in the business. Duties and Responsibilities: • Supervises areas related to Document Control and Document Change Management activities across 2 sites; • Ensure the proper number of Document Control Coordinators are on staff and available to perform necessary duties. Ensure all staff are properly qualified and trained to perform their assigned tasks; • Review Quality related documentation to assure quality records are generated and maintained properly; • Assure quality indicator data is logged for use as historical information for problem analysis and solution. Monitor non-conformance for trends in order to detect any developing issues. Bring this attention to management so that action plans can be developed to address these issues; • Interact with other functions to ensure good communication and resolution of issues; • Monitor direct reports compliance with applicable specifications and Good Manufacturing Practices; • Assure consistent and fair treatment for all Document Control Coordinators. Administer disciplinary action when required and approved by Quality Manager and Human Resources; • Ensures Device History Records are in good order prior to sending to Document Control for release of products and filing; • Own related departmental non-conformances and ensure timely completion of associated improvement actions. • Process and manage changes through the Agile change management system • Liaise with department staff on ensuring appropriate progress and management of change initiatives • Provide coherent and strong links with the Divisional Document Control Infrastructure to ensure cascading of Divisional Strategy into Local actions and operations • Provide communication on staff performance, capabilities and department metrics to Quality Manager on an agreed frequency • Provide department Subject Matter Expert support within Smiths Medical Audit Activities, either Internal, External or Corporate. • Foster a culture of proactive continual improvement, both at process and personnel level Required Skills and Experiences: • Strong educational background (ideally University Degree in a related field); • Extensive relevant experience in document control and document change management, ideally within a related industry (medical devices / medical / pharmaceutical); • Previous supervisory / people management experience, with the ability to effectively lead and motivate a team; and also provide technical subject matter support; • Strong IT skills (MS Office) and the ability to learn new systems quickly. • Ideally experience with Oracle Agile or similar systems. • Work well with others and analyse data/problems and provide solutions; • Good verbal and written communication skills. About Us: Smiths Medical is a leading global provider of medical devices for the hospital, emergency, home and specialist environments. Our products are used during critical and intensive care, surgery, post-operative care during recovery, and in a series of high-end home infusion therapies. We offer 11 of the most respected and easily recognisable brands within our portfolio: Portex™, Medex™, Deltec™, Level1™, Pneupac™, CADD™, BCI™, Jelco™, Medfusion™, Graseby™ and Surgivet™. Smiths Medical employs some 7,850 people, with manufacturing concentrated in the US, the UK, Mexico, Germany, Czech, China and Italy. Most territories are serviced through wholly-owned local sales and distribution companies. As part of Smiths Group plc, a FTSE 100 UK based company, Smiths Medical is well positioned to invest in continuous improvement, technological innovation and customer service