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Senior Quality Engineer - United Kingdom  

Company managed [?] Still accepting applications
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Posted on : 02 February 2017

Project Description

Division: Manufacturing
  • 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.   



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 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                                                



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 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