Supplier Quality Engineer

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.