We are currently seeking experienced Quality Engineers and Quality Assurance Professionals to join a leading Medical Device manufacturing company based in Cork.
Our client is expanding rapidly, transfering products from sister sites to their HQ in Ireland, and are looking for professionals to support their growth in this critical field.
Key Responsibilities: Lead and support quality assurance activities to ensure compliance with regulatory standards and internal quality systems.
Review and approve documentation such as product specifications, testing protocols, and quality control records.
Perform audits and inspections of manufacturing processes, systems, and products to ensure compliance with ISO standards and regulatory guidelines.
Collaborate with cross-functional teams, including engineering, manufacturing, and regulatory, to resolve quality issues and drive continuous improvements.
Participate in risk management activities, including failure mode effects analysis (FMEA), CAPA, and root cause analysis (RCA).
Maintain up-to-date knowledge of industry regulations and standards to ensure compliance.
Mentor and guide junior quality engineers (for senior-level candidates).
Develop, implement, and monitor quality assurance processes and procedures.
Conduct internal and external audits to ensure adherence to regulatory requirements and industry best practices.
Manage CAPA (Corrective and Preventive Actions) processes and ensure timely and effective resolution of quality issues.
Oversee validation and verification activities, ensuring compliance with standards and internal policies.
Ensure that all products are compliant with customer requirements, industry standards, and regulatory expectations.
Key Requirements: A Bachelor's degree in Engineering, Science, or a related field (required).
Mid-Level: 3+ years of experience in quality engineering or quality assurance within the medical device industry or a highly regulated environment.
Senior-Level: 5+ years of experience in quality engineering or quality assurance with a proven track record in leadership, project management, and delivering continuous improvement in quality systems.
In-depth knowledge of ISO 13485, FDA regulations, and other relevant standards (e.g., MDD, MDR).
Strong problem-solving and analytical skills with the ability to investigate and resolve quality issues effectively.
Excellent communication skills and the ability to work collaboratively in a fast-paced environment.
Attention to detail and a strong commitment to maintaining high-quality standards.
If you are a highly motivated and experienced Quality Engineer or Quality Assurance Professional ready to take the next step in your career, apply today
Skills: quality assurance qa quality engineer qe