My client who are based in Sligo are looking for a Quality Engineer to join their team as they expand operations.
As a Quality Engineer, you will play a critical role in ensuring compliance with regulatory standards and maintaining the highest level of quality for our products. This is an excellent opportunity to work in a dynamic and innovative environment with a talented team of professionals. If you are looking to take the next step in your career and make a significant impact, we invite you to apply for this exciting opportunity.
Responsibilities | Detailed Job Description Available on Request
As a Quality Engineer, you will:
Provide technical quality support to various stakeholders such as Project Manager, Design Engineers, Production Manager, and clients, ensuring compliance with relevant regulatory standards and procedures.
Collaborate with the Engineering team and clients to establish and maintain product specifications that comply with applicable regulatory requirements.
Review process validation plans, protocols, and reports to ensure that they meet regulatory requirements and company standards.
Contribute to the generation and maintenance of product risk management files, ensuring that they are compliant with regulatory standards and company procedures.
Review and approve lot records for manufacturing, and coordinate the testing and release of sterilized products.
Ensure that Standard Operating Procedures (SOPs), work instructions, material specifications, and templates comply with regulatory requirements and good manufacturing practices (cGMP).
Review and approve product change controls, liaise with suppliers and clients on quality-related issues, and assist in the investigation and resolution of non-conformances and customer complaints.
Support the Quality Management System (QMS) by performing internal audits, generating associated documentation, and participating in the continuous improvement of the system.
Support clients in the submission of products to regulatory authorities, conduct CAPA reports, and assist in the preparation for customer and surveillance audits.
A relevant Science or Engineer degree.
A minimum of 3 years experience.
Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
Strong knowledge of MDR & FDA product submission requirements.
Strong understanding of the general principles of ISO 14971.
What You'll Receive
Company Pension Scheme
Continued Professional Development Support
Annual Leave Service increment
Bike to work scheme
Subsidised Sport & Social Club
Bi-annual Company events
Employee Wellbeing Programme of Events
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.