Senior Quality Engineer

at  Collins McNicholas

Sector: Science & Pharma
Contact Email: cathal.herron@collinsmcnicholas.ie
Job Ref: 22775
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.

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.

• 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.