Senior Quality & Design Assurance Engineer

Mason Alexander; Maynooth; Ibrido; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

Mason Alexander is recruiting for a Senior/Principal level Quality & Design Assurance Specialist/Engineer for a medical device client in Ireland. The role focuses on QMS, design control and supplier quality in a fast-paced, early-stage environment.

The position is based in Cherrywood, South Dublin, with flexibility to be on site 3 days per week. You will collaborate across engineering, process development and external manufacturing partners to ensure GMP readiness and product quality.

Competenze

• 5+ years of quality experience in medical device/biotech environments.
• Strong knowledge of ISO 13485 design controls and design assurance processes.
• Experience with supplier quality management and CMOs.
• Excellent technical writing, organizational and project management skills.

Mansioni

• Maintain and improve the QMS, GMP readiness and related processes.
• 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 CAPA closure.
• Oversee supplier quality, including supplier qualification, supplier audits and Quality Technical Agreements.
• Review supplier documentation and batch records; manage change notifications and validation records.
• Support design assurance activities in line with ISO 13485, including DHF and design reviews.
• Coordinate design control documentation and track actions for product development and launch objectives.
• Provide support for regulatory documentation and submissions as required.

Conoscenze

Quality management

Design assurance

Regulatory knowledge

Documentation writing

Project management

Autonomous work

Strumenti

Electronic QMS platform

Descrizione del lavoro

Mason Alexander is recruiting for a Senior/Principal level Quality & Design Assurance Specialist/Engineer for a medical device client in Ireland. The role focuses on QMS, design control and supplier quality in a fast-paced, early-stage environment.

The position is based in Cherrywood, South Dublin, with flexibility to be on site 3 days per week. You will collaborate across engineering, process development and external manufacturing partners to ensure GMP readiness and product quality.