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.

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