Senior Quality & Design Assurance Specialist - 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

Senior/Principal level Quality & Design Assurance Specialist/Engineer

Our medical device client is seeking an experienced Quality & Design Assurance professional to support its QMS, design control and supplier quality activities within a fast-paced, early-stage environment. This is a hands-on role suited to someone who can work independently, manage multiple priorities and collaborate across engineering, process development and external manufacturing partners.

This role is based in Cherrywood, South Dublin. Flexibility to be on site 3 days per week.

Key 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, Quality Technical Agreements 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, design inputs and outputs, design reviews, verification and validation, FMEAs and Design History Files (DHF).
• Coordinate design control documentation and track actions required to support product development and launch objectives.
• Provide support for regulatory documentation and submissions, as required.

Key Requirements

• At least 5 years of experience working with Quality in medical device or biotechnology environments.
• Practical experience using an electronic QMS platform.
• Strong knowledge of ISO 13485 design controls and design assurance processes.
• Demonstrated experience managing change controls, deviations, CAPAs and internal audits.
• Experience in supplier quality management and working with contract manufacturing organisations (CMOs).
• Excellent technical writing, organisational and project management skills.
• Ability to work autonomously, manage competing priorities and adapt to changing requirements in an early-stage company.

Desirable/Advanced Experience

• Onboarding new CMOs, including supplier qualification and design transfer.
• Working with single-use assemblies, moulded components or medical device sub-assemblies.
• Software validation and lifecycle management.
• Sterilisation assurance, biocompatibility or extractables and leachables.
• Knowledge of EU and FDA regulatory frameworks for medical devices and/or ATMP/CGT technologies.
• Experience with Drug Master File (DMF) processes and regulatory submission preparation.
• Effective use of AI tools to improve working efficiency, supported by appropriate critical review.

The Ideal Candidate

A proactive, technically strong Quality professional who combines hands-on QMS experience with design assurance capability. They will be comfortable working in a small, cross-functional team, engaging directly with internal stakeholders and external suppliers, auditors and regulatory consultants while helping maintain robust quality standards in a growing organisation.