Supplier Quality Engineer

Sigmar Recruitment; Galway; On-site; EUR 55,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Discretionary annual bonus

Long-term incentive plans

Job summary

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.

Responsibilities

• 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.

Skills

Quality mindset

Problem solving

Communication

Attention to detail

Organisational skills

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Six Sigma

Job description

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.