Medical Device Quality Assurance Specialist

5 days ago

Sligo, Sligo, Ireland TN Ireland Full time

**About TN Ireland**

We are a leading provider of innovative medical devices, committed to delivering high-quality products that meet the evolving needs of healthcare professionals and patients.

The Role

We are seeking a highly skilled Quality Engineer to join our team in [location]. As a key member of our quality assurance department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements and industry standards.

**Key Responsibilities:

  1. Provide technical quality support to project managers, design engineers, production managers, and clients.
  2. Work closely with engineering teams and clients to establish and maintain compliant product specifications.
  3. Conduct quality reviews of process validation plans, protocols, and reports.
  4. Coordinate and contribute to the generation and maintenance of compliant product risk management files.
  5. Issue, review, and release of lot records to manufacturing.
  6. Coordinate and review testing and release of sterilized products.
  7. Conduct quality reviews of SOPs, work instructions, templates, material specifications, etc., to ensure compliance with applicable regulatory standards and cGMP procedures.
  8. Review and approve product change controls.
  9. Liaise with suppliers and clients on quality-related issues.
  10. Perform an active role in maintaining, further developing, and continuously improving the QMS.
  11. Support the QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints.
  12. Prepare CAPA reports.
  13. Support clients in product submissions to applicable regulatory authorities.
  14. Conduct internal audits and compile associated documentation.
  15. Support preparation for customer and surveillance audits.
  16. Maintain and update job knowledge by participating in educational opportunities.

**Requirements:**

  1. Minimum degree in a science or engineering discipline.
  2. At least 3-5 years' experience working in a medical device environment.
  3. Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
  4. Strong knowledge of MDR & FDA product submission requirements.
  5. Internal/external auditing experience would be advantageous.
  6. Validation experience including sterilization, process, and packaging validations would be beneficial.
  7. Knowledge of medical device manufacturing environments, including cGMP, would be an advantage.
  8. Strong understanding of the general principles of ISO 14971.
  9. Strong decision-making ability, coupled with the ability to work independently with minimal supervision and multitask/prioritize effectively.
  10. Demonstrate detailed working knowledge of the medical device industry.
  11. Excellent written and verbal communication skills, enabling effective communication with diverse engineering teams, project management, suppliers, and customers.
  12. Excellent attention to detail with strong numerical and problem-solving abilities, while maintaining awareness of longer-term objectives.
  13. Proficiency in MS Office (Word, Excel, PowerPoint, etc.).

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