Hobson Prior are looking for a Quality Manager to join an organisation who help control infection and drive down the cost of high-quality medical products. As the Quality Manager you will ensure the organisation undertakes all operational activities in accordance with the requirements of ISO 9001, ISO 13485, EU and UK Medical Device Regulations and current EU medicinal product GMP and GDP.

Job Responsibilities:

• Management of the Quality Team at Mountain Ash (and Girvan?).
• Management of the NCR/CAR Process, ensuring timely completion of actions and appropriate documentation.
• Management of the Internal Audit Programme, ensuring that the annual schedule is issued and adhered to.
• Management of the Supplier Audit Programme, ensuring that the annual schedule is issued and adhered to on a risk basis.
• Ensure that the organisation is aware of changes to relevant national and international standards and to manage implementation of changes.
• Management of customer complaint investigations related to product quality.
• Management of the company Calibration programme, ensuring that all measuring equipment that has an impact on product quality is calibrated in accordance with national or international standards.
• Management of the Goods-In Inspection Process, ensuring that a risk-based approach is taken.
• Management of the production quality assurance programme, ensuring that appropriate in-process and finished product inspections are undertaken, scrap is logged, concessions, deviations and reworks are approved.
• Management of the process validation programme, providing technical support and organising writing of protocols and reports.
• Represent as a Responsible Person under EU GDP Guideline 2013/C 343/01.
• Provide support to planning, procurement and commercial teams for new processes, changes, deviations and substitutions.
• Provision of training in relevant topics as required.

Key Skills:

• Computer literate, especially in Word and Excel tools such as pivot tables.
• Excellent communication and presentation skills and the ability to engage with all levels of staff from the shop floor to senior management.

Requirements:

• BSc Honours degree in relevant engineering or scientific discipline, or equivalent.
• Knowledge and understanding of the Medical Device Directive/Medical Device Regulations, ISO 9001 and ISO 13485.
• Knowledge and understanding of EU medicinal product GMP and GDP requirement.
• Experience of working within a GMDP and ISO 13485 regulated organisation
• Knowledge and experience in the use of quality tools such as cause and effect diagrams, pareto analysis, SPC and continuous improvement techniques such as lean and 5S
• Experienced trainer.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.