Our client is a leading company within the medical device Industry, dedicated to improving patient outcomes through innovative and high-quality products. With a commitment to excellence and adherence to strict regulatory standards, our client is at the forefront of delivering cutting-edge solutions to healthcare providers worldwide. They are seeking a dynamic and experienced Senior Quality Engineer to join their team. The successful candidate will play a pivotal role in ensuring compliance with ISO13485:2016 and other relevant standards, driving continuous improvement initiatives, and maintaining the highest standards of product quality and reliability.
Responsibilities:
- Lead key elements of the quality system to ensure compliance with ISO13485:2016 and industry standards.
- Coordinate quality-related activities across various domains, including Quality Systems, Converting Quality, and Added Value Service Quality.
- Generate reports for data trending and analysis of the quality system, providing insights for improvement.
- Conduct or coordinate investigations, root cause analysis, and implementation of corrective and preventive actions for customer complaints, CAPA, and non-conformances.
- Oversee and approve all phases of assigned events and investigations to ensure thoroughness and accuracy.
- Prepare comprehensive reports with associated data and conclusions to demonstrate project completion and effectiveness.
- Manage time, workload, performance, and development of direct reports, fostering a culture of accountability and continuous learning.
- Ensure timely completion of projects by effectively managing day-to-day project activities and resources.
- Cultivate positive working relationships and effective communication with internal cross-functional departments to facilitate collaboration and problem-solving.
- Support site readiness for audits, including first, second, and third-party audits, as well as unannounced audits, by implementing robust processes and documentation.
Requirements:
- Bachelor's degree in science/engineering or equivalent third-level qualification.
- Minimum of three years of experience in Quality Engineering within a manufacturing environment, preferably in the medical device industry.
- Training and/or experience in working in an ISO13485:2016 certified manufacturing environment.
- Proven track record of previous people management experience, demonstrating leadership and team development skills.
- Strong planning and coordination skills, with the ability to prioritize and manage multiple tasks effectively.
FULL SPEC ON APPLICATION
If you are interested in learning more about this fantastic opportunity, please contact Cathal Herron:
cathal.herron@collinsmcnicholas.ie
(090) 645 0660