Senior Quality Engineer
We are seeking a highly motivated and experienced Senior Quality Engineer to join our expanding team in Galway.
Key Responsibilities:
* Maintain and improve the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards.
* Lead internal and external audits, ensuring preparedness and addressing findings effectively.
* Collaborate with cross-functional teams to ensure design control processes are followed during product development.
* Provide quality oversight and risk management support for new product introductions (NPIs).
* Develop and execute validation protocols (IQ/OQ/PQ) for processes, equipment, and systems.
* Investigate non-conformances, lead root cause analysis, and implement effective corrective and preventive actions.
* Assess and qualify suppliers, ensuring they meet regulatory and company quality requirements.
* Support manufacturing operations to ensure adherence to quality standards.
Requirements:
* Bachelor's degree in Engineering, Science, or a related discipline.
* A minimum of 5-7 years of experience in quality engineering within the medical device industry.
* Deep understanding of ISO 13485, FDA 21 CFR Part 820, and MDR/IVDR requirements.
* Proven experience with design control, process validation, and risk management methodologies.
* Strong analytical and problem-solving skills.
* Excellent communication and interpersonal skills.
* ASQ certification (e.g., CQE) or Lean Six Sigma Green/Black Belt is highly desirable.
Estimated Salary: $120,000 - $160,000 per year