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Senior Quality Engineer -Complaints

Excellent Salary, Benefits and relocation package - Quality
Ref: 86 Date Posted: Friday 06 Oct 2017
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Senior Quality Engineer - Complaints - Medical Devices

Excellent Salary, Benefits and relocation package

Our clients 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.

 

Role Summary

Key role is to ensure that customer complaints investigations are performed in a thorough and timely manner. Participate in the design and manufacturing process to ensure products meet SQCD 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.

Key Results Areas

  • Maintain acceptable level of in-house and supplied product and material quality.
  • Continuation of manufacturing processes and exceptional customer satisfaction of product performance and quality.
  • Compliance with Health & Safety & Environmental procedures
  • Successful completion of mandatory training
  • Regulatory compliance, Delivery of objectives & Demonstrate improvement.

 

Principal Responsibilities

  • Support the Customer Concerns Coordinator for managing the customer complaint process.
  • 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)

 

Other Duties

  • Product compliance testing & reporting
  • Participate in Continuous Improvement activities
  • Will undertake any assignment or duty as required by business needs.
  • Will undertake any assignment or duty as required by business needs.
  • Independently determine approach and assigned tasks
  • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
  • Liaise and communicate with other departments, customers, suppliers and other service providers

 

Qualifications and 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.  

Specialists in consultancy


At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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