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Senior Quality Engineer Southend-on-Sea United Kingdom,  


Posted on : 02 February 2017

Project Description

Division: Manufacturing (KeyMed) As part of the Olympus global manufacturing community, Olympus KeyMed's Manufacturing Business Centre plays a key role in the development and manufacture of new, sophisticated medical and industrial products. Working with colleagues in Europe, the USA and Japan, our multi-disciplinary team of R&D engineers is fully equipped with the latest computer-aided design and modelling technologies, to enable them to develop medical workstations and fluid management products & accessories, and industrial Remote Visual Inspection devices.Producing world class products in terms of Quality, Cost and Delivery isn't just desirable, it's essential. Therefore, in today's fast moving, ever changing world, we continue to invest in both our people and the latest equipment and processes to remain at the forefront in manufacturing technology. Your Responsibilities: Participate in the design and manufacturing process to ensure products meet SQCD requirements. Key role in ensuring product issues are promptly investigated and adequate corrective/preventive action implemented e.g. customer complaints, out of specification components, etc. Responsible for ensuring that the products produced meet quality standards required to minimise quality costs and maximise customer satisfaction whilst ensuring that procedures and processes are adhered to. Lead and manage cross functional project teams to resolve complex quality problems, which may have significant impact to the business e.g. product recalls, production downtime, patient safety, external regulatory action. Generate control plans Review and approval of technical documents Participate and lead problem solving teams Supply chain development Project management. Routine control of product sterilization processes. Validation of products sterilization processes. Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or system Produce written reports and make presentations Lead in techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis, and Process Failure Mode and Effects Your Qualifications: Bachelors Degree, or equivalent, in an Engineering or Biological Sciences Discipline. Five years experience in a Quality Engineering role within a Medical Device, Sterile single use, Electro-Mechanical or Electronics Manufacturing environment. Experience in a Medical Device facility and knowledge of ISO13485 and FDA Quality System Regulations (21 CFR 820) would be advantageous. Your Competencies:The interview will be competence based and the following competencies will be assessed: Continuous improvement Delivering results Problem solving, creativity& decision making Project management Further information:All applications must be received by the closing date of 10th February 2017 and will not be accepted after this deadline. You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006.

Locations

Southend on Sea UK

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