Quality Engineer

Potential for hybrid

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) by 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.