Job Title: Quality Engineer Location: Cork, Ireland Industry: Medical Devices Looking to progress your career as a Quality engineer or make the step up from Quality Technician to Engineer?
This role in a global Medical Device leading company will offer you excellent career opportunities in a dynamic working environment.
Overview The Quality Engineer will support manufacturing operations in line support, drive continuous improvement, and ensure compliance with regulatory and quality system requirements.
The role includes investigation work, documentation control, and day-to-day support of production lines.
Key Responsibilities Provide quality support to manufacturing lines to ensure product and process compliance.
Lead and contribute to CAPA investigations and Non Conformances ensuring timely closure and effective implementation of corrective and preventive actions.
Perform root cause analysis using structured problem-solving tools (e.g., 5 Whys, Fishbone).
Maintain and update quality documentation, including procedures, work instructions, and validation records.
Support nonconformance management, including investigation, documentation, and disposition activities.
Monitor quality metrics and support initiatives to improve process capability and reduce defects.
Participate in internal and external audits, assisting with preparation and follow-up actions.
Collaborate with cross-functional teams including Manufacturing, Engineering, R&D, and Regulatory Affairs.
Ensure all work complies with ISO *****, FDA, and applicable regulatory requirements.
Requirements Bachelors degree in Engineering, Science, or a related field.
Minimum 2 years of experience in a medical device or other highly regulated industry.
understanding of quality systems, regulatory standards, and GMP requirements.
Experience with CAPA processes, root cause analysis, and structured problem-solving tools - DMAIC Strong documentation skills with attention to accuracy and compliance.
Ability to support day-to-day manufacturing quality issues in a fast-paced environment.
Good communication and teamwork skills.
For more details about this role get in touch Contact Gary Keane Email - Call - INDCRG Skills: line support CAPA Process Development Troubleshooting Validation Design DMAIC