Senior Quality Engineer - Design Transfer Lead

GxP Recruitment; Kilkenny; On-site; EUR 90,000 - 120,000; Full time

Job summary

GxP Recruitment seeks an experienced Senior Quality Engineer - Design Transfer (Analytical Methods) to support DTQA activities in a regulated pharmaceutical or medical device environment.

The role focuses on ensuring designs are ready for commercialisation, guiding on Design Controls, reviewing design outputs for manufacturability, and translating designs into production-ready documentation while managing risks across multiple projects with minimal supervision.

Qualifications

• 10+ years of experience in a regulated pharmaceutical, medical device, biotechnology or similarly controlled manufacturing environment.
• Strong practical experience with Design Controls and Quality Systems.
• Significant experience across the full product lifecycle including design, verification, validation and transfer.

Responsibilities

• Engage with projects early to ensure product, process and site readiness for commercialisation.
• Provide expert guidance on Design Controls and Design Transfer requirements.
• Review design outputs to ensure manufacturability before final product specs.
• Translate product designs into component specs, production specs and manufacturing methods.
• Ensure that documentation released to production is verified and validated.
• Plan and execute verification and validation activities for Design Transfer.
• Identify quality, design transfer and manufacturing risks and mitigate them.
• Collaborate with Engineering, R&D, Quality, Manufacturing, Operations, Regulatory and PM teams.
• Provide Quality input into project plans and commercialisation activities.
• Ensure Design Control deliverables comply with procedures and regulatory requirements.
• Support resolution of technical and quality issues throughout Design Transfer.

Skills

10+ years experience

Design Controls

Design Transfer

Quality Systems

Cross-functional teams

Regulated environment

Education

Engineering/Science degree

Job description

GxP Recruitment seeks an experienced Senior Quality Engineer - Design Transfer (Analytical Methods) to support DTQA activities in a regulated pharmaceutical or medical device environment.

The role focuses on ensuring designs are ready for commercialisation, guiding on Design Controls, reviewing design outputs for manufacturability, and translating designs into production-ready documentation while managing risks across multiple projects with minimal supervision.