Job Description
Quality Engineer - Medical Device Industry Location: Dublin, Ireland Job Type: Full-time, On-site (Potential for hybrid) Salary: €75,000 - €85,000 per annum (Negotiable DOE) Our client is an innovative medical device start-up based in Dublin, committed to transforming patient care through cutting-edge technology. As they continue to grow, they are looking for a dedicated and experienced Quality Engineer to join their team. Key Responsibilities: Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485, ISO 14971, and 21 CFR 820 regulations. Ensure all products meet regulatory and quality standards from development through to production and post-market. Conduct internal audits and manage external audits to ensure compliance with applicable standards and regulations. Collaborate with cross-functional teams to identify and resolve quality issues and improve processes. Create, review, and approve quality documentation including SOPs, risk management files, validation protocols, and reports. Participate in design reviews, ensuring quality and regulatory requirements are integrated into product designs. Provide training and support to staff on quality system procedures and regulatory requirements. Monitor and report on key quality metrics and implement continuous improvement initiatives.Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field. Minimum of 5 years of experience in quality assurance within the medical device industry. In-depth knowledge of QMS standards and regulatory requirements including ISO 13485, ISO 14971, and 21 CFR 820. Proven track record of managing audits and regulatory inspections. Strong problem-solving skills and ability to work in a fast-paced, start-up environment.Benefits Package: Healthcare cover. Pension. Dental Plan. Reperio Human Capital acts as an Employment Agency and an Employment Business