My client is a fast expanding Medical Devices organization in the northwest that is now looking for a QA/RA Director to join their team to maintain their strong compliance record during sustained growth.
• Lead the move towards a ‘paperless environment’, driving all document handling activitie towards the approved systems.
• Ensure that the Quality function in the UK works in compliance with the Quality Policy and associated objectives as well as the strategy to achieve them and advises the Operational management team.
• To ensure that the Quality Management System is defined, implemented and maintained; relevant and coherent with regard to the general objective, expectations and needs of the external and internal customers.
• Overall responsibility for the management of the company’s internal audit and CAPA programmes including ensuring satisfactory and timely implementation of actions arising from these programmes.
• Oversee the undertaking of internal audits within business and if appropriate of key suppliers, highlighting key trends and action requirements.
• Handling of customer complaints record, vigilance or MDR notification to the relevant competent authorities and coordinating Field Safety Corrective Actions.
• Coordinate Quality activities such as Supplier auditing and qualification.
• Manage audits performed by Regulatory Authorities (including the FDA, BSI, MHRA, Pharma Authorities, Human Tissue Authorities) from readiness preparation to positive closure of any identified Non Conformity.
• Act as Management Representative according to the requirements of ISO 13485.
• Effectively comply with the requirements for EU Authorised Representative for US legacy entities described by EU MDD.
• Work in conjunction with the UK Commercial QA/RA Manager to ensure that PMS is handled and acted upon in the most appropriate manner.
• You will be well versed in the Quality System approaches needed for ISO and CE standards through 5-10 years’ experience working in a Quality and Regulatory capacity
• Excellent leadership skills to coach team members and support their growth and career aspirations
• A willingness to be hands on with technical work when needed.
• Exacting in your communication with good scientific understanding with ability to synthesize information and formulate effective arguments.
• Strong presentation skills.
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 019 5972. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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