Quality Engineer

Role Overview:
My client, a leading global provider of optimized manufacturing solutions for high precision medical plastics products are recruiting a Quality Engineer to join their team. The Quality Engineer will assist the Quality Operations Manager in implementing the Quality Management System and support the quality team in the Leixlip manufacturing site.

Responsibilities:

• Interface with customers to ensure satisfaction and address quality concerns effectively.

• Oversee production GMP standards, conduct root cause investigations, implement corrective actions (CAPAs), and manage non-conformance reports (NCRs).

• Establish inspection standards, maintain FMEAs, and update quality system documentation.

• Support customer and accreditation audits, with a focus on compliance with ISO 13485 and other regulatory requirements.

• Play an active role in quality planning for new product introductions.

• Drive quality system development and continuous improvement initiatives in operations and processes.

• Train personnel on quality procedures, ensure GDP compliance for records, and manage material disposition and sample storage.

• Requires a relevant degree or equivalent experience (1+ years in high-volume manufacturing), strong communication skills, and a proactive approach to problem-solving.

• Audit and validation experience are advantageous, along with the ability to work both independently and collaboratively.