Olympus Southend-on-Sea SS2 5QH, United Kingdom
Jan 27, 2017Full time
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. 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. The Senior Quality Engineer will Participate in the design and manufacturing process to ensure products meet SQCD requirements. You will play a 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.