My client are specialists in design, developing and manufacturing components for medical devices, industrial and electrical/appliances industry products and are now looking to grow their Quality Department to ensure the Quality System is of the highest standard with particular focus on validations and non-conformances.
Key Responsibilities Implement and maintain quality system to the international standard ISO 13485, ISO 9001 and all applicable regulations under the Medical Device regulation.
Product Development: Participate in and support all aspects of new product development, production trials, sampling and production runs of new materials and finished products as needed.
Validation: Assist with the generation of validation protocols and reports, including data analysis and test scrips as required.
Report on relevant quality performance data and drive continuous improvement processes within the organisation through change control activities.
Partake as the owner of internal non-conformances including support of investigation processes when not the owner.
Monitor vendors and issue NCMRs where necessary and ensure problem vendors are identified and controls implemented to prevent problem reaching company product.
Carry out internal audits as per ISO 13485 programmes.
You will work closely alongside other Quality Assurance Personnel to learn from and to work as part of the Quality Team and also alongside the Operations Lead / Production Manager to liaise with production team on quality issues.
Your Competencies The successful candidate will have: Quality experience with understanding of validation (doesn't have to have done validation duties but this is a bonus) 2-3 years experience in quality engineering ISO 13485 med device experience For more information, contact Alan with your most up to date CV to Skills: Quality Engineer Quality Validation ISO13485