MedTech QA Manager: QMS Owner, Hybrid Dublin

TRICARDIA; Dublin; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

TRICARDIA in Dublin, Ireland is seeking a hands-on Quality Assurance Manager for a medical device startup to own the QMS and drive quality across R&D, Regulatory and clinical programmes.

The role is hybrid, offering close collaboration with senior leadership and cross-functional teams. You will manage ISO 13485, CAPA, audits, design controls and risk management to support the company’s next development phase.

Qualifications

• 5+ years of experience in medical device Quality/Quality Systems.
• Strong knowledge of ISO 13485.
• Experience owning or managing a medical device QMS.
• Experience in start-up, scale-up or small medtech companies.
• Good understanding of EU MDR and FDA quality requirements.
• Experience with CAPA, change control, audits and non-conformances.
• Experience with design controls and risk management.
• Experience with Notified Bodies and regulatory authorities.
• Strong communication skills and ability to work across a small cross-functional team.
• Practical, independent working style.

Responsibilities

• Ownership and maintenance of the ISO 13485 QMS.
• CAPA, non-conformances, deviations and change control.
• Document control and quality records.
• Design controls and product development activities.
• Risk management and ISO 14971.
• Verification and validation activities.
• Internal and external audits.
• Supplier quality and quality agreements.
• Supporting Notified Body and regulatory interactions.
• Working with R&D, Clinical and Regulatory teams.
• Identifying and implementing improvements to the QMS.
• Ensuring the quality infrastructure develops with clinical and regulatory programmes.

Skills

Quality management

Regulatory awareness

Cross-functional collaboration

Problem solving

Job description

TRICARDIA in Dublin, Ireland is seeking a hands-on Quality Assurance Manager for a medical device startup to own the QMS and drive quality across R&D, Regulatory and clinical programmes.

The role is hybrid, offering close collaboration with senior leadership and cross-functional teams. You will manage ISO 13485, CAPA, audits, design controls and risk management to support the company’s next development phase.