Senior Quality Engineer - Complaints Posted May 09
Recruit Zone , Southend-on-sea, Essex, United Kingdom
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As part of the Olympu 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. 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.

This is a key role to ensure that customer complaints investigations are performed in a thorough and timely manner.

Your 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

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

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.

Employment Type: Permanent
Duration: Permanent
Work Hours: Full Time