We are looking for a Quality Engineer to join an expanding medical device engineering company located in Sligo. 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.
What You'll Receive
- Company Pension Scheme
- Health Insurance
- Continued Professional Development Support
- Educational Assistance
- Annual Leave Service increment
- Bike to work scheme
- Subsidised Sport & Social Club
- Bi-annual Company events
- Employee Wellbeing Programme of Events
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.
As a Quality Engineer, you should have:
- 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.
If this Engineering Assistant role interests you, please contact Emma Cawley today.