Senior Quality Assurance Manager

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

Quality Assurance Manager | Medical Device

Location: Dublin, Ireland

Working model: Hybrid

Tricardia is working with an early-stage medical device company developing innovative structural heart technology. They are now looking to appoint a QA Manager to take ownership of the company's quality function.

This is a hands-on opportunity for someone who has worked in a medical device start-up or small, growing medtech business and enjoys having genuine responsibility for the QMS.

You will work closely with the senior leadership team, R&D, Clinical and Regulatory, helping to ensure the quality systems are robust and fit for the company's next stage of development.

The role

The QA Manager will take responsibility for the day-to-day management and continued development of the company's QMS.

Responsibilities include:

• 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 closely with R&D, Clinical and Regulatory teams
• Identifying and implementing improvements to the QMS
• Ensuring the quality infrastructure develops alongside the company's clinical and regulatory programmes

The person

We're looking for someone hands-on rather than someone looking to manage a large team.

You'll ideally have:

• 5+ years' experience within medical device Quality / Quality Systems
• Strong knowledge of ISO 13485
• Experience owning or managing a medical device QMS
• Experience working in a start-up, scale-up or smaller medical device company
• 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 working with Notified Bodies and/or regulatory authorities
• Strong communication skills and the ability to work across a small, cross-functional team
• A practical approach and the ability to work independently

Experience within cardiovascular, structural heart, interventional or implantable devices would be particularly relevant.

Why consider it?

This is a great opportunity for someone who wants to have a real impact within a growing medical device business.

Rather than being one person within a large Quality organisation, you'll have direct ownership of the QMS and the opportunity to influence how the quality function develops as the company progresses through its next phase.