Senior Quality Engineer - Medical Device

Mason Alexander; Dublin; On-site; EUR 70,000 - 100,000; Full time

Job summary

Mason Alexander is seeking a Senior Quality Assurance Engineer - Clinical & Design Quality (Contract) in Dublin, Ireland. The role supports pivotal clinical studies across the US and Europe, partnering with Clinical, R&D, Manufacturing, Supply Chain and external partners to ensure quality system compliance.

The ideal candidate will have 5+ years in medical device QA, with experience in regulated environments, design control activities, and risk management.

Qualifications

• Degree in Engineering, Sciences or related technical discipline.
• 5+ years QA experience in medical device industry.
• Experience supporting clinical studies for medical devices.
• Strong understanding of ISO 13485, ISO 14155, FDA QSR, EU MDR, Design Controls and ISO 14971.

Responsibilities

• Provide QA support for pivotal clinical study activities per regulatory requirements and procedures.
• Oversee clinical operations quality documentation review/approval.
• Ensure compliance with ISO 13485, FDA QSR, MDR, ISO 14155, ISO 14971 and internal QMS.

Skills

Quality Assurance

Regulatory compliance

Clinical studies

Documentation review

Education

Degree in Engineering, Sciences

Job description

Senior Quality Assurance Engineer - Clinical & Design Quality (Contract)

Location: Dublin, Ireland (Hybrid)

Contract: 12 months (Contract)

About the Role

A growing Medical Device company based in Dublin are seeking an experienced Quality Assurance Engineer to support the Quality team during a critical phase of product development to prepare for and execute a pivotal pre-commercial clinical study across the United States and Europe.

This role will partner closely with Clinical, R&D, Manufacturing, Supply Chain and external partners to ensure quality system compliance and effective quality oversight throughout the clinical programme. The successful candidate will have experience working within regulated medical device environments and be comfortable operating in a fast-paced, cross-functional setting.

Key Responsibilities

• Provide Quality Assurance support for pivotal clinical study activities in accordance with applicable regulatory requirements and company procedures.


• Support quality oversight of clinical operations, including review and approval of clinical quality documentation.


• Ensure compliance with ISO 13485, 21 CFR Part 820 (or the Quality Management System Regulation/Quality Management System requirements as applicable), Good Clinical Practice (ISO 14155), and internal Quality Management System procedures.


• Participate in Design Control activities, including design reviews, design changes, risk management, and verification of design documentation.


• Review and approve protocols, reports, specifications, and quality records supporting the clinical programme.


• Support supplier and external partner quality activities where required.


• Assist with management of nonconformances, deviations, CAPAs and change controls related to clinical and development activities.


• Participate in internal and external audits and support inspection readiness.


• Collaborate with cross-functional teams to identify quality risks and implement effective mitigation strategies.


• Contribute to continuous improvement initiatives within the Quality Management System.

Qualifications

• Degree in Engineering, Sciences or a related technical discipline.


• Minimum 5 years' Quality Assurance experience within the medical device industry.


• Experience supporting clinical studies for medical devices.


• Strong understanding of ISO 13485, ISO 14155, FDA Quality System requirements, EU Medical Device Regulation (MDR) & Design Controls and Risk Management (ISO 14971)


• Excellent document review, communication and stakeholder management skills.


• Ability to work independently while collaborating effectively across multidisciplinary teams.


• Experience in start-up or rapidly growing medical device organisations.


• Experience working with Class III or implantable medical devices is an advantage.

What You'll Bring

• A pragmatic, hands-on approach to Quality Assurance.


• Strong attention to detail and sound technical judgement.


• Excellent organisational and problem-solving skills.


• The ability to manage multiple priorities while maintaining compliance and quality standards.


• A collaborative mindset with a passion for improving patient outcomes through innovative medical technology.

This contract offers the opportunity to play a key role in supporting a pivotal clinical programme for an innovative medical device as it progresses toward commercialisation, working alongside multidisciplinary teams in a dynamic and mission-driven environment.