Senior Quality Engineer
Southend-on-sea, Essex, United Kingdom
Job type: fulltime
Job industry: Engineering
Participate in the design and manufacturing process to ensure products meet requirements. Assures that all products represent the maximum quality and reliability attainable. 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. Work on multiple phases or sub-tasks of projects or entire projects of high complexity, with results impacting on project completion.
Work reviewed at project milestones and/or on completion by Senior Management. Work under minimal supervision. 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.
Qualifications & Experience
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.
* 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 Analysis (PFMEA)