Our client a medical device scale up are looking to hire a Senior Quality Engineer as they expand operations.
The Role
I am seeking a highly motivated and experienced Senior Quality Engineer to join our expanding team in Galway. This role is integral to ensuring the highest standards of quality and compliance in our medical device product development and manufacturing processes. The ideal candidate will bring a proactive approach to quality assurance, thrive in a fast-paced environment, and have a strong passion for continuous improvement.
Responsibilities
Quality Management System (QMS):
Maintain and improve the QMS to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory standards.
Lead internal and external audits, ensuring preparedness and addressing findings effectively.
Design and Development:
Collaborate with cross-functional teams to ensure design control processes are followed during product development.
Provide quality oversight and risk management support for new product introductions (NPIs).
Process Validation:
Develop and execute validation protocols (IQ/OQ/PQ) for processes, equipment, and systems.
Monitor and analyze validation data to ensure robust and repeatable processes.
Non-Conformance and CAPA:
Investigate non-conformances, lead root cause analysis, and implement effective corrective and preventive actions.
Monitor CAPA effectiveness and drive continuous improvement initiatives.
Supplier Quality Management:
Assess and qualify suppliers, ensuring they meet regulatory and company quality requirements.
Manage supplier audits and work closely with vendors to resolve quality issues.
Production Support:
Support manufacturing operations to ensure adherence to quality standards.
Implement and monitor statistical process controls (SPC) and other quality tools to ensure product consistency.
Training and Mentorship:
Provide training on quality systems, processes, and regulatory requirements to team members.
Mentor junior engineers and contribute to the professional growth of the quality team.
Qualifications and Experience
Bachelor’s degree in Engineering, Science, or a related discipline.
A minimum of 5-7 years of experience in quality engineering within the medical device industry.
Deep understanding of ISO 13485, FDA 21 CFR Part 820, and MDR/IVDR requirements.
Proven experience with design control, process validation, and risk management methodologies (e.g., FMEA, ISO 14971).
Strong analytical and problem-solving skills with experience in root cause analysis tools (e.g., 5 Why’s, Fishbone).
Excellent communication and interpersonal skills to work effectively with cross-functional teams.
ASQ certification (e.g., CQE) or Lean Six Sigma Green/Black Belt is highly desirable.
For more information and a confidential discussion on the role, please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717