Senior Quality & Design Assurance Engineer - Medical Device

Mason Alexander; Dublin; Hybrid; EUR 75,000 - 120,000; Full time

Job summary

Mason Alexander supports a medical device client in Dublin for a Senior/Principal Quality & Design Assurance Specialist. The role is hands-on, requires independent work and collaboration with engineering, process development and external manufacturing partners.

It is based in Cherrywood, with on-site work three days a week. The ideal candidate has 5+ years in quality in medical device or biotech, strong ISO 13485 design controls, change control, CAPA and supplier quality management, and can

Qualifications

• At least 5 years of quality experience in medical device or biotech environments.
• Strong knowledge of ISO 13485 design controls and design assurance processes.
• Experience with change controls, deviations, CAPAs and internal audits.
• Supplier quality management and CMOs experience.
• Excellent technical writing, organization and project management skills.

Responsibilities

• Maintain and improve the QMS, supporting GMP operations and GMP readiness.
• Develop, review and approve SOPs, work instructions and technical documentation.
• Manage change controls, deviations, CAPAs, root cause investigations and effectiveness checks.
• Coordinate internal audits, track findings and ensure timely CAPA closure.
• Oversee supplier quality, including supplier qualification, CMO audits, QTA and ongoing performance monitoring.
• Review supplier documentation, including batch records, change notifications, validation and qualification records.
• Support design assurance activities in line with ISO 13485, including design plans, inputs/outputs, reviews, verification/validation, FMEAs and DHF.
• Coordinate design control documentation and track actions to support product development and launch.
• Provide support for regulatory documentation and submissions, as required.

Skills

QMS management

Technical writing

Project management

Regulatory knowledge

Tools

eQMS

Job description

Mason Alexander supports a medical device client in Dublin for a Senior/Principal Quality & Design Assurance Specialist. The role is hands-on, requires independent work and collaboration with engineering, process development and external manufacturing partners.

It is based in Cherrywood, with on-site work three days a week. The ideal candidate has 5+ years in quality in medical device or biotech, strong ISO 13485 design controls, change control, CAPA and supplier quality management, and can