Quality Compliance & Improvement Officer - Based Bedfordshire
Our client is a market leading Medical Device organisation, who have a unique opportunity to join a progressive Medical Disposables organisation. The role will be working as a Quality Compliance & Improvement Manager and will be based in our client's Head Office, based in Bedfordshire. Our client is looking for dynamic and self-motivated individuals who have the desire to develop a long term career within their business. The successful candidate be responsible for supporting the Quality Compliance and Improvement Management Systems within the business, ensuring compliance to ISO 13485, Medical Devices Regulations and other ISO standards. Essential Requirements: Proven experience in the role of ISO-13485, QC Officer or equivalent. Clean Room knowledge is essential. Educated to degree level in a scientific field or equivalent experience. Self-motivated and able to work under own initiative. Methodical and professional approach to role. Excellent communication skills both written and verbal. Excellent attention to detail. Enthusiastic, "can do" attitude. Excellent computer skills - Microsoft Office. Role Responsibilities: To ensure that high quality standards are maintained. Implement the company's quality policy as documented by the company QMS. Continually improve and maintain the Quality Management Systems, ensuring company compliance to ISO 13485:2016. Promoting quality achievement and continuous improvement throughout manufacturing. Manage the internal and external audit programs. Lead regulatory visits, corporate, vendor and internal audits. Monthly reporting on key Company KPI's. Liaise with both internal and external stakeholders regarding non-conformance issues. Proactive management of supplier performance. Ensure that all necessary paperwork is filed according to company and regulatory requirements.