Quality Engineer – Leitrim
Our client offers full Product Lifecycle Solutions to the Medical Device and Pharmaceutical Sectors in support of new product development programmes.
From a Quality perspective, you will support projects in design, analysis development and commercialisation of complex innovative products. Our client are entering an ambitious growth phase and are looking for high calibre personnel to contribute to the team in achieving their goals.
As Quality Engineer will report to the Quality Manager and your main aspects of the role include;
· Co-ordinating the site calibration program to ensure all calibration is performed on time and in a compliant manner.
· Co-ordinating the site preventative maintenance program to ensure all maintenance is performed on time and in a compliant manner.
· Assure quality products and processes, and Quality Standard Compliance by establishing and maintaining a compliant QMS.
· Establish and maintain a permanent improvement process of the QA Organization and of the Quality System.
· Ensures the full compliance of QA activities with ISO 13485 and other quality system requirements.
Day to day responsibilities;
· Establish, maintain and continuously improve the company’s quality systems, procedures and policies.
· Investigate Customer Complaints and raise Non-conforming material reports, CAPA’s and change controls when required.
· Ensure product inspections take place in line with company procedures.
· Provide support to Incoming Quality Inspection.
· Internal Auditing
· Supplier Auditing
· Preparing for and engaging in surveillance audits by the Notified Body.
· Trending of Quality Data as required, identify and implement changes or improvements to existing systems.
· Supports all Validation activities within the company including processing Validations directly when required.
· Perform project tasks to ensure timely completion of QMS project milestones.
· Provide training and support to all staff on QMS processes including risk management, validation, GxP, QMS procedures, forms, etc.
Requirements for the role
· Minimum qualifications Ordinary or Hons Degree in a Quality or Engineering discipline.
· Good problem solving, oral and written communication skills.
· Highly motivated and detail-oriented to deliver assigned tasks.
· Ability to work as part of a multi-disciplinary team of toolmakers, engineers and senior management.
· Strong people skills.
· Understanding of the regulatory landscape associated with medical device industry desired but not essential.
For a confidential discussion and more information on the role, please contact Davin Ferguson.