Supplier Quality Engineer

EPM Scientific; Sligo; On-site; EUR 55,000 - 70,000; Full time

Job summary

EPM Scientific invites applications for a Supplier Quality Engineer on a 12-month contract, based onsite in Ireland (North of Ireland). The role interfaces with internal teams and external manufacturers to ensure compliance with ISO 13485, MDR, and regulatory requirements, while driving CAPA and continuous improvement.

The successful candidate will manage investigations, supplier audits, and change control, coordinating with contract manufacturers and third-party suppliers in a fast-paced,

Qualifications

• Proven background in a regulated manufacturing environment, preferably medical devices.
• Experience working with third party manufacturers, contract manufacturers, or suppliers.
• Strong understanding of investigations, CAPA, non-conformances, and change control processes.
• Working knowledge of ISO 13485 and MDR requirements.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities and drive projects to completion in a fast paced environment.
• Must be currently based in Ireland and available to work onsite 5 days per week.

Responsibilities

• Act as the primary quality contact for third-party manufacturers and external suppliers.
• Lead and support investigations into non-conformances, deviations, complaints, and quality-related issues.
• Drive root cause analysis and CAPA activities to ensure effective resolution of quality events.
• Monitor supplier performance through quality metrics and key performance indicators.
• Review and approve quality documentation in line with internal and regulatory requirements.
• Support change control activities and assess potential quality and compliance impacts.
• Participate in supplier audits, quality reviews, and regulatory inspections.
• Identify opportunities for continuous improvement across supplier quality and external manufacturing operations.

Skills

Regulatory

CAPA

Root Cause

Supplier Quality

Stakeholder Management

Project Management

Tools

ISO 13485

Quality Documentation

Job description

Supplier Quality Engineer | 12 Month Contract

Location: North of Ireland (Must be based in Ireland)

Onsite Requirement: 5 days per week

Contract Length: 12 Months

A leading healthcare manufacturer is seeking a Supplier Quality Engineer. This role will act as the key interface between internal teams and external manufacturing partners, ensuring products are manufactured in compliance with regulatory requirements, quality standards, and business expectations.

This is an excellent opportunity for a quality professional with experience in medical devices, supplier quality, or external manufacturing environments who is looking to contribute to a fast-paced and highly regulated organisation.

Key Responsibilities

• Act as the primary quality contact for third-party manufacturers and external suppliers.
• Lead and support investigations into non-conformances, deviations, complaints, and quality-related issues.
• Drive root cause analysis and CAPA activities to ensure effective resolution of quality events.
• Monitor supplier performance through quality metrics and key performance indicators.
• Review and approve quality documentation in line with internal and regulatory requirements.
• Support change control activities and assess potential quality and compliance impacts.
• Participate in supplier audits, quality reviews, and regulatory inspections.
• Identify opportunities for continuous improvement across supplier quality and external manufacturing operations.

Experience & Requirements

• Proven background in a regulated manufacturing environment, preferably medical devices.
• Experience working with third party manufacturers, contract manufacturers, or suppliers.
• Strong understanding of investigations, CAPA, non-conformances, and change control processes.
• Working knowledge of ISO 13485 and MDR requirements.
• Excellent communication and stakeholder management skills.
• Ability to manage multiple priorities and drive projects to completion in a fast paced environment.
• Must be currently based in Ireland and available to work onsite 5 days per week.