Senior Quality Engineer - United Kingdom
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- As part of the company manufacturing community, company's Manufacturing Business Center 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.
- 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 minimize quality costs and maximize 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
- 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 would be advantageous.
- Continuous improvement
- Delivering results
- Problem solving, creativity& decision making
- Project management