Quality Assurance Professional
3 days ago
Established in Westmeath, ACCPRO is a specialist company that designs, develops and manufactures components for medical devices, industrial and electrical/appliances industry products.
The company aims to grow its Quality Department to ensure the Quality System meets the highest international standards with particular focus on validations and non-conformances.
About the Role- This is an exciting opportunity for a Quality Assurance Professional to join our team and contribute to the development of quality systems and processes.
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.
We are looking for a candidate with 2-3 years experience in quality engineering and ISO 13485 med device experience.
Your 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 scripts 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 NCMR's 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.
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