Design Quality Engineer: NPI & Regulatory Compliance

Trinity Biotech; Bray; On-site; EUR 60,000 - 90,000; Full time

Job summary

Trinity Biotech seeks a Design Quality Engineer to develop and implement compliance strategies for NPI and current products across design, transfer, manufacturing and service.

You will ensure QMS adherence and regulatory requirements are met, using critical thinking to drive robust quality decisions, patient safety, audit readiness, and enable commercial delivery of Trinity Biotech products.

Qualifications

• Bachelor’s degree in QA, engineering, life sciences, or related field.
• 3+ years in a design quality role in medical devices.

Responsibilities

• Develop, implement, and maintain design quality assurance processes in compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards.
• Collaborate with R&D to integrate quality into product development lifecycle.
• Conduct design reviews and FMEA to identify and mitigate risks.
• Develop and validate test methods, inspection procedures, and QC processes.
• Manage design verification and validation activities for regulatory compliance.
• Create documentation for global regulatory submissions and liaise with external bodies.
• Support DHF and DMR creation in line with regulatory requirements.
• Lead root cause analysis and CAPA for design issues.
• Develop and monitor quality KPIs to drive design quality improvements.
• Prepare and present design quality reports to management.
• Provide training on quality principles to R&D and manufacturing.
• Stay updated on industry standards and regulatory updates.

Skills

Analytical thinking

Problem solving

CAPA experience

Communication

Team collaboration

Attention to detail

CQE certification (plus)

Education

Bachelor’s degree in QA/Engineering/Life Sciences

ASQ CQE certification (plus)

Tools

Minitab

Job description

Trinity Biotech seeks a Design Quality Engineer to develop and implement compliance strategies for NPI and current products across design, transfer, manufacturing and service.

You will ensure QMS adherence and regulatory requirements are met, using critical thinking to drive robust quality decisions, patient safety, audit readiness, and enable commercial delivery of Trinity Biotech products.