We are seeking a Quality Assurance Specialist to join our team in Cork, Ireland. The ideal candidate will have a strong understanding of quality systems and regulatory standards.
Job Description
The Quality Assurance Specialist will support manufacturing operations by ensuring product and process compliance. Key responsibilities include providing quality support to manufacturing lines, leading CAPA investigations and Non-Conformances, performing root cause analysis using structured problem-solving tools, maintaining and updating quality documentation, supporting nonconformance management activities, monitoring quality metrics and participating in internal and external audits.
Required Skills and Qualifications
* Bachelors degree in Engineering or Science
* Minimum 2 years of experience in a medical device industry
* Understanding of ISO 13485, FDA regulations and GMP requirements
The successful candidate will have strong communication skills with the ability to work effectively with cross-functional teams including Manufacturing Operations Management Technical Support Engineering Research Development Regulatory Affairs as well as liaise closely technical vendors medical devices manufacturers international authorities similar professional bodies.