We are supporting our medical device client who are looking to hire a Senior Design Assurance Engineer as their business grows. This is a permanent role based in Galway which requires an onsite presence.
Key Responsibilities
1. Lead quality activities including risk assessments, device testing, validations, audits, and technical documentation.
2. Manage Design History File (DHF) and support continuous improvement of the QMS.
3. Ensure product development and risk management activities comply with company procedures and regulatory requirements.
4. Translate user needs into design and manufacturing requirements, including test method development and process monitoring.
5. Conduct design verification, validation, and test method validation.
6. Collaborate with R&D, Manufacturing, suppliers, and external stakeholders to resolve issues and ensure quality standards are met.
7. Apply problem-solving and statistical analysis techniques to product development and manufacturing processes.
8. Represent the medical device client professionally to regulators, vendors, and auditors.
9. Support compliance activities such as CAPA, audits, and training.
10. Review and approve operational, test, and validation data to confirm product conformance.
11. Provide quality guidance, mentorship, and technical support to staff.
Essential Skills & Experience
12. Bachelor's degree in Engineering, Science, or related technical field.
13. Minimum 6 years of QA, Quality Systems, or regulatory experience in the medical device industry, including at least 4 years in design and development QA.
14. Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU MDR, Canadian MDR and related international regulations.
15. Experience supporting audits, inspections and regulatory interactions.
16. Strong project management, leadership and communication skills.
17. Proficiency in MS Office and statistical tools (., Minitab).
18. Results-driven, self-motivated, with strong decision-making and problem-solving skills.