Design Quality Engineer: Shape Healthcare Diagnostics

LGC; Tipperary; On-site; EUR 52,000 - 80,000; Full time

Benefits offered by this job

25 days holidays

Life assurance

Health allowance

Discounts

Employee assistance program

Career progression

Job summary

LGC Clinical Diagnostics in Tipperary, Ireland is hiring a Design Quality Engineer to support the Design Control process, maintain Design History Files, and lead change control activities across R&D, Validation and Manufacturing. The role emphasises regulatory compliance and risk management across product lifecycle.

With a background in science or engineering and at least two years in a quality function, you will help ensure high-quality diagnostics products, work with cross-functional teams,

Qualifications

• Educated to a minimum of degree level in Science/Engineering/QA or related discipline or equivalent.
• A minimum of 2 years practical experience required in a quality function or equivalent.
• Knowledge desirable in relation to risk management; ideally in the IVD or Medical Device industry.
• Thorough knowledge of the applicable regulatory requirements.
• Knowledge of international regulatory requirements relevant to the business.

Responsibilities

• Support Design Control processes and ensure Design History Files comply with policies and regulatory requirements.
• Act as the Quality representative on Design Control projects from initiation to product launch.
• Lead and manage the change control process with involved areas for timely, compliant implementation.
• Collaborate with R&D, Labelling, Operations, Validation, BD and Supply Chain on design/control projects.
• Review and approve process validation documentation including plans, protocols and reports.

Skills

Quality assurance

Risk management

Regulatory knowledge

Education

Bachelor's degree in Science/Engineering/QA or related discipline

Job description

LGC Clinical Diagnostics in Tipperary, Ireland is hiring a Design Quality Engineer to support the Design Control process, maintain Design History Files, and lead change control activities across R&D, Validation and Manufacturing. The role emphasises regulatory compliance and risk management across product lifecycle.

With a background in science or engineering and at least two years in a quality function, you will help ensure high-quality diagnostics products, work with cross-functional teams,