White Rose Recruitment Limited Location:
Trading in Leeds since 1974, our client is a specialist manufacturers of silicone tubing and surgical devices used in operating theatres. They supply products to the N.H.S, distributors and private hospitals around the U.K. as well as exporting to many organisations worldwide.
Many of their products have been designed in response to requests from leading surgeons and operating theatre personnel and include drains and tubing, ear, nose and throat products, general surgical equipment, and laser protection, which are mainly manufacture, and hand finished from their premises in Leeds.
Responsibilities and duties
- To maintain the Quality Management System (QMS) and put forward for approval any amendments or improvements that are identified;
- To monitor and ensure that the requirements of the Quality Manual are implemented throughout the Company;
- Authorised to carry out Internal Quality Audits, and to provide performance reports on the effectiveness of the Quality System as a basis for monitoring improvements. This is to be done in consultation with the Quality Engineer and the Management team;
- Assist in the investigation of all customer complaints with the Customer Services Team and CEO;
- Maintain the customer complaints files;
- Carry out calibration functions, such as calibration of plug gauges, and entry of relevant information in the calibration register (monthly / yearly);
- Work in support of the Procurement and QC Inspector;
- Working with the Regulatory and Quality Manager, the jobholder will be responsible for ensuring that regulatory and customer requirements are established and met;
- Monitoring and analysing critical to quality features in production to identify trends and provide early warning of potential quality issues, and will support all aspects of product quality verification and validation;
- Working to ensure the QMS and associated processes are adhered to and compliant with the Regulations;
- Assist in the compilation and review of standard operating procedures, work instructions and other relevant documentation to ensure compliance with the QMS to ISO 9001 and ISO 13485;
- Perform internal audits to ISO 9001 and ISO 13485 and non-routine quality and product audits of the manufacturing areas and relevant product;
- Perform external critical supplier audits annually of as required;
- Quality monitoring and trending of production processes;
- Liaise with production department to reduce scrap levels in production processes;
- Analyse data for trending to identify areas for improvement in the quality system;
- Day to day running of the quality management systems and processes including, but not limited to, goods in, inspection activities, internal compliance audits in line with ISO13485, product inspections, document control and identification and control of non-conforming products.
Qualifications and skills
The Quality Manager will ensure compliance with the legal requirements for all medical devices regulations, CE marking, licensed product for design, manufacture and sale for the QMS and Technical Files.
The jobholder will have a good first degree in a relevant scientific discipline and ideally, relevant experience in the medical devices industry. Equally important, the jobholder must have a working knowledge of quality standards ISO 9001, ISO 13485, the Medical Device Directive (MDD 93/42/EEC) and possess computer competency in Microsoft office software, data collection and general analysis tools.
Job Type: Full-time
- medical devises quality management: 1 year
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