Supplier Quality Engineer - Medical Devices (Galway)

Sigmar Recruitment; Galway; Sur place; EUR 55 000 - 85 000; Plein temps

Avantages offerts par ce poste

Competitive salary

Discretionary annual bonus

Long-term incentive plans

Résumé du poste

Sigmar Recruitment is seeking a Supplier Quality Engineer for a permanent, on-site role in Galway in the medical devices sector. You will manage supplier quality activities, maintain ASL, and apply SPC and IQ/OQ/PQ methodologies to ensure high-quality components and services.

Key tasks include leading 8D investigations, reviewing non-conformances, conducting supplier audits, and supporting CAPA, supplier transfers, and continuous improvement while ensuring FDA, EU MDR, and QMS compliance.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Minimum of two years' experience in Quality Engineering or Supplier Quality within a manufacturing environment.
• Working knowledge of plastics injection moulding and assembly processes.
• Strong communication and problem-solving skills with good written/spoken English.
• Excellent organisational skills and attention to detail.

Responsabilités

• Manage supplier quality activities ensuring compliance with quality standards, regulatory requirements and procedures.
• Maintain and update the Approved Supplier List (ASL) for supplier assessment and qualification.
• Apply quality engineering tools including SPC, process capability studies, IQ/OQ/PQ.
• Lead 8D investigations and drive CAPA with suppliers to prevent recurrence.
• Review supplier non-conformances and customer complaints; ensure investigations and resolutions.
• Conduct supplier audits and close corrective actions in a timely manner.
• Collaborate with cross-functional teams to resolve quality issues and support business goals.
• Support delivery of conforming components via acceptance criteria, AQL sampling, and incoming inspection.
• Contribute to CAPA, supplier transfers and continuous improvement initiatives.
• Help maintain supplier compliance with FDA, EU MDR and QMS requirements.

Connaissances

Quality mindset

Problem solving

Communication

Attention to detail

Organisational skills

Formation

Bachelor's degree in Engineering

Outils

Microsoft Office

Six Sigma

Description du poste

Sigmar Recruitment is seeking a Supplier Quality Engineer for a permanent, on-site role in Galway in the medical devices sector. You will manage supplier quality activities, maintain ASL, and apply SPC and IQ/OQ/PQ methodologies to ensure high-quality components and services.

Key tasks include leading 8D investigations, reviewing non-conformances, conducting supplier audits, and supporting CAPA, supplier transfers, and continuous improvement while ensuring FDA, EU MDR, and QMS compliance.