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Quality Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22257

My client who are based in Sligo are looking for a Quality Engineer to join their team as they expand operations.

The Role:

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.

Requirements

  • 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

  • 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

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717