Senior Quality Assurance Engineer
Location: Galway, Ireland
The Opportunity
My client, a clinical-stage medical device manufacturer, is seeking an experienced and innovative Quality Engineer to join their growing QA/RA team in Galway. This role offers the opportunity to work on the development of minimally invasive medical devices designed to treat chronic venous disease, with involvement across the full product lifecycle, from early concept through regulatory approval and global patient use.
This position is based at my client's Galway City offices.
Key Responsibilities
- Develop, implement, and continuously improve a compliant, workflow-based Quality Management System in line with ISO 13485 and 21 CFR Parts 808, 812, and 820.
- Plan, implement, and coordinate quality assurance activities including quality specifications, processes, training, CAPA, validation and verification documentation, and material safety specifications.
- Coordinate and support supplier assessment, selection, and qualification activities.
- Support internal and external audits.
- Review and update QMS documentation to ensure alignment with current industry standards.
- Apply design control, risk management, and quality engineering principles throughout product development.
- Support quality activities related to device manufacturing, including inspection standards, test methods, and control plans.
- Prepare and maintain technical and regulatory documentation in compliance with applicable requirements.
- Contribute to design verification and validation strategies in collaboration with R&D, Manufacturing, and Regulatory Affairs.
- Apply risk management principles in accordance with EN ISO 14971.
- Generate and maintain risk management documentation, including Risk Management Plans, Hazard Analyses, DFMEA, PFMEA, and Risk Management Reports.
- Manage records related to design control and risk management in accordance with QMS requirements.
- Support the development of test methods for product evaluation, verification, and validation, including statistical justification and risk-benefit analysis.
Requirements
- Bachelor's degree in Science, Engineering, or a related discipline.
- Minimum 5 years' experience in Quality Assurance within a Class II medical device environment.
- Strong knowledge of Quality Systems with demonstrated experience implementing or improving QMS processes.
- ISO 13485 Lead Auditor qualification is desirable.
- Experience working closely with R&D in areas such as GMP, process validation, change control, CAPA, auditing, and risk management (including FMEA).
- Familiarity with electronic document control systems.
- Ability to interpret regulatory and internal requirements to ensure compliance with design control, risk management, and QMS standards.
- Strong problem-solving skills with a systematic, results-driven approach.
- Experience preparing technical and regulatory documentation.
- Excellent written and verbal English communication skills.
- Highly organised with strong attention to detail and a quality-focused mindset.
- Ability to work effectively in a small, collaborative team and inspire others.
- Proven results-focused work practices with honest self-assessment against objectives.
- Comfortable working in a start-up or small-company environment, or willing to adapt.
- Strong desire for continuous learning and professional development within the medical device industry.
- Ability to manage multiple priorities and active projects simultaneously.
- Values honesty, transparency, and proactive issue resolution.
