Supplier Quality Engineer

Collins McNicholas Recruitment; Kilkenny; On-site; EUR 55,000 - 75,000; Full time

Job summary

Collins McNicholas Recruitment is seeking an experienced Supplier Quality Engineer for an initial 12-month subcontracting role in Ireland. You will manage supplier quality issues, audits, and validation activities across a regulated manufacturing environment.

The role involves improving supplier performance, handling SCARs, CAPAs, and change notifications, and supporting IQ/OQ/PQ validation with cross-functional teams. Suitable candidates have strong QA background and regulatory exposure.

Qualifications

• Degree in Engineering, Science or related discipline.
• 3+ years in Supplier Quality or Quality Engineering in a regulated industry.
• Experience managing SCAR/CAPA & supplier non-conformances.
• Experience supporting IQ/OQ/PQ process validation.
• Working knowledge of ISO 13485 and FDA QMSR.
• Understanding of PFMEA risk tools.
• Strong supplier & stakeholder management.
• Experience with mechanical or moulding suppliers; Veeva QMS, Minitab; ISO 13485 Lead Auditor/ASQ CQE/CSQE certs advantageous.

Responsibilities

• Manage SCARs from initiation to verified closure.
• Review supplier change notifications for quality, regulatory and validation impact.
• Support IQ/OQ/PQ validation, FAI and PPAP-style activities.
• Conduct desktop and onsite supplier audits and drive resulting actions.
• Monitor supplier quality performance and support scorecard reviews.
• Maintain supplier quality records and agreements within the eQMS.
• Support material review and supplier non-conformance activities.
• Collaborate with suppliers and internal stakeholders to drive corrective actions.

Skills

SCAR/CAPA management

IQ/OQ/PQ validation

Risk management (PFMEA)

SPC and capability studies

Stakeholder management

Quality engineering in regulated env.

Regulatory knowledge

Education

Bachelor’s degree in Engineering/Science or related

Tools

Veeva QMS

Minitab

Job description

We are looking for anexperienced Supplier Quality Engineer to join a leading regulated manufacturing organisation. Please note this is an initial 12-month subcontracting role.

You will support a diverse supplier base, managing supplier quality issues, change notifications, audits, validation activities, and continuous supplier performance improvement.

Key Responsibilities

• Manage Supplier Corrective Action Requests (SCARs) from initiation through verified closure
• Review Supplier Change Notifications and assess quality, regulatory and validation impacts
• Support supplier IQ/OQ/PQ validation, First Article Inspection (FAI) and PPAP-style activities
• Conduct desktop and onsite supplier audits and manage resulting actions
• Monitor supplier quality performance and support supplier scorecard reviews
• Maintain supplier quality records and agreements within the eQMS
• Support material review and supplier non-conformance activities
• Work with suppliers and internal stakeholders to drive corrective actions and quality improvements

Requirements

• Degree in Engineering, Science or related discipline
• 3+ years' Supplier Quality or Quality Engineering experience within a regulated industry
• Experience managing SCAR/CAPA and supplier non-conformances
• Experience supporting IQ/OQ/PQ process validation
• Working knowledge of ISO 13485 and FDA QMSR
• Understanding of risk management tools such as PFMEA
• Good statistical analysis skills, including SPC and capability studies
• Strong supplier and stakeholder management skills
• Experience with mechanical or moulding suppliers, Veeva QMS, Minitab, ISO 13485 Lead Auditor or ASQ CQE/CSQE certification would be advantageous