R&D Quality Officer - Warwickshire

25000.00 - 30000.00 GBP Annual
07 Mar 2019
27 Mar 2019
Contract Type
Do you have quality and regulatory experience and are looking for a new position? I'm currently handling an R&D Quality Officer with a polymer and materials manufacturing company for use in the medical devices industry, based at their site in Warwickshire on a full time permanent basis.

The Company:
Our client is an established manufacturer of materials used in the medical devices industry. Reporting in to the Director of Research and Development with a dotted line to the Head of QA RA for NPD compliance, this role attracts a salary in the region of GBP25-30,000 depending on experience. The successful candidate will be responsible for supporting research and development within the business ensuring compliance to ISO 13485 and FDA standards. The key purpose of the role will be to work closely with the Research and Development department and Quality Assurance department to ensure that the Quality System and documentation relating to the company's R&D process are appropriate to ensure compliance and support product registration filings.

The Role:
?? Ensure compliance to all applicable standards, regulations and internal procedures by proactively interpreting quality and regulatory requirements and implementing solutions.
?? Manage interface between R&D and QMS.
?? Maintain compliance of NPD through design control systems and audits.
?? Maintain and control product design history files.
?? Prepare quality documentation by collecting, analysing and summarising information and trends including audit findings, non-conformances, customer complaints, corrective and preventive actions.
?? Manage and perform internal audits, along with management and implementation of corrective actions.
?? Administration of electronic document control system, contributing to the drafting of documentation, approval, reviewing and implementation of internal QMS documentation in accordance with ISO13485, FDA CFR 820 part 21 and MDD.
?? Co-ordinate change control activities, including design change control.
?? Co-ordinate equipment calibration/ maintenance activities.
?? Administration of electronic CAPA system database including co-ordinating and investigation of non-conformances an management and implementation of corrective and preventive actions.
?? Act as a Lead Auditor once training has been completed.

Your Background:
The ideal candidate for this role will have the following skills and experience:
?? Significant Quality Assurance experience.
?? A demonstrable strong working knowledge and experience of applying ISO 13485, FDA 820 part 21 and MDD standards and regulations within the Medical Device or IVD industries.
?? Experience of participation in internal and/ or external audits.
?? Clean room and GMP knowledge/ experience.

Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.

CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 44737 in all correspondence.