Design Quality Engineer - Impacting Healthcare Diagnostics

LGC Group; Tipperary; On-site; EUR 45,000 - 65,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Discounts with retailers

24/7 Employee Assistance Programme

Recognition schemes & monetary awards

Long-term career opportunities

Job summary

LGC Clinical Diagnostics in Tipperary, Ireland, invites applications for a Design Quality Engineer. You will ensure Design Control compliance and drive change control across R&D, Validation and Operations to support safe diagnostic products.

Join a team focused on quality, integrity and patient safety, performing audits, risk assessments and Post-Market activities while advancing your career in a dynamic healthcare environment.

Qualifications

• Degree in Science/Engineering/QA or related discipline.
• At least 2 years’ experience in a quality function or equivalent.
• Knowledge of risk management and regulatory requirements (IVD/Medical Device).

Responsibilities

• Support the Design Control process and ensure Design History Files meet TCD policies and regulatory requirements.
• Act as the QA representative on Design Control projects from initiation to launch.
• Lead change control liaising with affected areas for timely, compliant implementation.
• Collaborate with R&D, Labelling, Operations, Validation, and Supply Chain on design/change control projects.
• Review and approve validation documents (plans, protocols, reports) for compliance.
• Maintain Risk Management Files for each product and facilitate FMEA reviews.
• Maintain Design Control and R&D procedures to ensure regulatory compliance.
• Perform Post Market Surveillance per procedures and regulations.
• Liaise with external customers on change requests and provide staff training on design/change control.

Skills

Quality Assurance

Design Control

Regulatory knowledge

Risk Management

Education

Degree in Science/Engineering/QA

Job description

LGC Clinical Diagnostics in Tipperary, Ireland, invites applications for a Design Quality Engineer. You will ensure Design Control compliance and drive change control across R&D, Validation and Operations to support safe diagnostic products.

Join a team focused on quality, integrity and patient safety, performing audits, risk assessments and Post-Market activities while advancing your career in a dynamic healthcare environment.