Join a leading organisation that provide innovative products to suit the continuing needs for patients requiring stoma care, urology & continence care, and wound care.Our client is seeking an experienced Quality Specialist to support the Quality Management Systems within the business, ensuring compliance and regulations are maintained.
This is a full-time position, ideally working Monday to Friday (9am to 5pm) based predominantly at their Buckinghamshire head office.Ideal Requirements for the Quality Specialist * Proven quality experience in the Medical Devices industry. * Expert knowledge of ISO9001, ISO13485.
* Ideally experience of ISO14001 and knowledge/awareness of ISO14971. * Experience of internal auditing. * Experience interpreting, implementing, and communicating changes in Regulatory policy and Quality standards. * Ability to engage and influence internal and external customers and champion a positive quality culture across the business.
* Ideally experience in developing quality strategy, external auditing. * Educated to degree level in a scientific, engineering, or relevant discipline.Role Responsibilities for the Quality Specialist * Review, maintain and develop the company QMS system to ensure compliance with relevant standards (ISO 9001, ISO 14001 and working with the Regulatory function on ISO13485) and applicable regulations.
* Implement the Company’s Quality and Environmental Policy as documented in the Quality and Procedures Manual. * Drive QMS improvement in usability, visibility, and engagement.
* Work with the Quality & Regulatory Affairs Administrators and relevant departments to monitor and improve the complaints processes related to service, distribution and dispensing of product. * Assist the business in developing SOPs to maintain compliance.
* Review existing SOPs and approve as necessary, offering input to streamline processes where possible. * Ensure Good Distribution Practice is followed in relation to relevant processes. Work with the Responsible Person to monitor and ensure compliance. * Provide training on quality aspects and standards to all levels of the business as required.
* Lead on change control within the QARA Department. * Participate in continuous improvement, corrective actions, and business risk minimisation.Role Specific Competencies for the Quality Specialist * Ability to prioritise, plan and organise workload and work to deadlines.
* Highly IT literate. * Highly numerate with an excellent level of attention to detail. * Excellent written communication and presentation skills.Recruitment Process2/3 stage process.Interested? Please click apply, or contact Claire on (phone number removed) to discuss further!
Evolve is a leading recruitment and outsourcing organisation, operating within the Pharmaceutical, Healthcare, Medical Device and Life Science sectors
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