Supplier Quality Engineer
Location: Galway
Permanent - Full-Time
Sector: Medical Devices
The Opportunity
We are seeking a Supplier Quality Engineer to join a leading organisation in the medical device sector. This is an excellent opportunity for a quality professional to play a key role in ensuring supplier performance, product quality, and compliance with stringent regulatory and quality management system requirements.
Working closely with suppliers and cross-functional teams, you will support supplier qualification, auditing, corrective actions, and continuous improvement initiatives to ensure the consistent delivery of high-quality components and services.
Key Responsibilities
Manage supplier quality activities for components, ensuring compliance with applicable quality standards, regulatory requirements, and internal procedures.
Maintain and update the Approved Supplier List (ASL), supporting supplier selection, assessment, and qualification.
Apply quality engineering tools and methodologies, including Statistical Process Control (SPC), process capability studies, and IQ/OQ/PQ.
Lead 8D investigations and drive supplier corrective and preventive actions to address quality issues and prevent recurrence.
Review supplier non-conformances and customer complaints, ensuring appropriate investigation and resolution.
Conduct supplier audits, follow up on audit findings, and ensure timely closure of corrective actions.
Collaborate with cross-functional teams, including Factory, Sourcing, CME, AME, and R&D, to resolve quality issues and support business objectives.
Support the timely delivery of conforming components through appropriate acceptance criteria, AQL sampling, and incoming inspection processes.
Contribute to CAPA activities, supplier transfers, and ongoing process improvement initiatives.
Help maintain supplier compliance with FDA, EU MDR, and internal Quality Management System (QMS) requirements.
Requirements
Bachelor’s degree in Engineering or a related technical discipline.
Minimum of two years’ experience in Quality Engineering or Supplier Quality within a relevant technical or manufacturing environment.
Working knowledge of plastic injection moulding and assembly processes.
Strong communication and problem-solving skills, with a good standard of written and spoken English.
Excellent organisational skills, attention to detail, and a dependable approach to managing priorities.
Proficiency in Microsoft Office applications.
Desirable Skills
Six Sigma Green Belt or Black Belt certification.
Experience with supplier audits, corrective action investigations, process validation, and continuous improvement methodologies.
What’s on Offer?
The opportunity to contribute to product quality and supplier performance within the medical device industry.
A collaborative, cross-functional working environment.
A competitive salary and benefits package, with compensation reflecting relevant skills, qualifications, experience, and location.
Eligibility for a discretionary annual bonus and potential participation in long-term incentive plans, subject to applicable company terms and role eligibility.
Apply Now
If you have experience in Supplier Quality and are interested in contributing to quality and compliance within a regulated manufacturing environment, we would welcome your application.
