Overview
Senior Design Assurance Engineer required by a medical device client. This is a permanent role based in Galway with onsite presence.
Key Responsibilities
* Lead quality activities including risk assessments, device testing, validations, audits, and technical documentation.
* Manage Design History File (DHF) and support continuous improvement of the QMS.
* Ensure product development and risk management activities comply with company procedures and 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 medical device client professionally to regulators, vendors, and auditors.
* Support compliance activities such as 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.
Qualifications
* 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 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 (e.g., Minitab).
* Results-driven, self-motivated, with strong decision-making and problem-solving skills.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance, Design, and Engineering
* Industries: Medical Equipment Manufacturing
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