We are looking for a top talent to support our medical device client in Galway. This is a permanent role requiring an onsite presence.
* Lead quality activities including risk assessments, device testing, validations, audits, and technical documentation.
* Manage Design History File (DHF) and support continuous improvement of the Quality Management System (QMS).
* Ensure product development and risk management activities comply with regulatory requirements.
* Translate user needs into design and manufacturing requirements, including test method development and process monitoring.
* Conduct design verification, validation, and test method validation.
* Collaborate with R&D, Manufacturing, suppliers, and external stakeholders to resolve issues and ensure quality standards are met.
* Apply problem-solving and statistical analysis techniques to product development and manufacturing processes.
* Represent the client professionally to regulators, vendors, and auditors.
* Support compliance activities such as Corrective Action Preventive Action (CAPA), audits, and training.
* Review and approve operational, test, and validation data to confirm product conformance.
* Provide quality guidance, mentorship, and technical support to staff.
Essential Skills & Experience
* Bachelor's degree in Engineering, Science, or related technical field.
* 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.
* Strong knowledge of FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, EU Medical Device Regulation (MDR), Canadian MDR and related international regulations.
* Experience supporting audits, inspections, and regulatory interactions.
* Strong project management, leadership, and communication skills.
* Proficiency in MS Office and statistical tools.
* Results-driven, self-motivated, with strong decision-making and problem-solving skills.