Quality Engineer

Prochem Engineering; Leinster; On-site; EUR 55,000 - 75,000; Full time

Job summary

Prochem Engineering in County Kilkenny, Ireland, is seeking a Quality Engineer to lead supplier quality activities on a medical device manufacturing site. The role focuses on managing supplier non-conformances, change notifications, audits, and validation support to drive supplier performance improvements.

The successful candidate will work within the regulated environment, applying ISO 13485 standards and QMS processes, conducting SCAR/SCN activities, and supporting process validations and

Qualifications

• Degree in Engineering, Science or a related discipline.
• Minimum 3 years' experience in Supplier Quality or Quality Engineering within a regulated industry.
• Working knowledge of ISO 13485 and FDA QMSR.
• Experience with SCAR/CAPA systems.
• Experience supporting process validation activities (IQ/OQ/PQ).
• Knowledge of PFMEA and risk management tools.
• Strong communication and stakeholder management skills.

Responsibilities

• Manage Supplier Corrective Action Requests (SCARs) from initiation through verified closure
• Process Supplier Change Notifications (SCNs) and assess quality, regulatory and validation impacts
• Support supplier process validations, First Article Inspections (FAIs) and PPAP-style submissions
• Conduct desktop and on-site supplier audits and manage follow-up actions
• Monitor supplier quality performance and participate in scorecard reviews
• Maintain supplier quality records and quality agreements within the eQMS
• Support material review activities

Skills

ISO 13485

FDA QMSR

SCAR/CAPA systems

IQ/OQ/PQ validation

PFMEA

Minitab

Stakeholder mgmt

SQ experience

Education

Bachelor's degree in Engineering/Science

Tools

Veeva QMS

Job description

Role Summary:

• Our client, based in County Kilkenny, is looking for a Quality Engineer to join the team at their medical device manufacturing site.
• This role supports the Supplier Quality function across a diverse supplier base.
• The successful candidate will manage supplier non-conformances, change notifications, audit activities and validation support, while driving supplier performance improvements.

Core Duties and Responsibilities:

• Manage Supplier Corrective Action Requests (SCARs) from initiation through verified closure
• Process Supplier Change Notifications (SCNs) and assess quality, regulatory and validation impacts
• Support supplier process validations, First Article Inspections (FAIs) and PPAP-style submissions
• Conduct desktop and on-site supplier audits and manage follow-up actions
• Monitor supplier quality performance and participate in scorecard reviews
• Maintain supplier quality records and quality agreements within the eQMS
• Support material review activities

Minimum Qualifications and Experience:

Essential Experience:

• Degree in Engineering, Science or a related discipline
• Minimum 3 years' experience in Supplier Quality or Quality Engineering within a regulated industry
• Working knowledge of ISO 13485 and FDA QMSR
• Experience with SCAR/CAPA systems
• Experience supporting process validation activities (IQ/OQ/PQ)
• Knowledge of risk management tools such as PFMEA
• Good statistical analysis skills (Minitab, SPC, capability studies)
• Strong communication and stakeholder management skills

Preferred Experience:

• ISO 13485 Lead Auditor qualification and/or ASQ CQE/CSQE certification
• Veeva QMS experience
• Experience with mechanical or moulding suppliers