We are seeking a Quality Engineer for our Medical Device client in Limerick to ensure quality and compliance throughout the product lifecycle, from development to commercialisation and beyond. The ideal candidate will be a proactive problem-solver with a solid understanding of quality management systems and a commitment to continuous improvement.
Key Responsibilities
- Provide quality assurance oversight for new product development, commercialisation, and sustaining activities.
- Act as a subject matter expert on quality issues, guiding teams on problem-solving, root cause analysis, and corrective actions.
- Contribute to process improvement by identifying and implementing effective statistical and quality control techniques.
- Manage quality documentation and records, including validation protocols, risk documents, and test methods, ensuring they meet regulatory standards.
- Lead or participate in quality-focused projects to drive efficiency and compliance.
- Support internal, customer, and regulatory audits and ensure full compliance with all relevant regulations.
- Collaborate effectively with cross-functional teams to meet quality and project goals.
Skills, Attributes & Experience
- Degree in Engineering, Quality, or a related discipline.
- Experience with relevant quality management systems (e.g., ISO 13485, FDA QSR, GMP).
- Proficiency in technical report writing and statistical analysis.
- Knowledge of structured problem-solving techniques and Lean principles.
- Strong ability to manage and drive projects to completion.
- The successful candidate must demonstrate strong time management and organisational skills.
