Senior Quality Engineer - QMS & Regulatory Leader

Trinity Biotech; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Trinity Biotech is seeking a Senior Quality Engineer to lead the development, maintenance and improvement of the Quality Management System in line with IVDR (EU 2017/746) and ISO 13485.

You will partner with R&D, Manufacturing, Regulatory Affairs, and suppliers to ensure product quality, regulatory compliance and lifecycle excellence, leading investigations, CAPA, risk management and audits.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Quality Management, or a related discipline.
• Minimum 5–8 years' experience in Quality Engineering or Quality Assurance within regulated industries (medical devices/IVD/pharma).
• Strong knowledge of IVDR (EU 2017/746) and ISO 13485.
• Experience with CAPA systems and validation processes.
• Internal auditing techniques and handling regulatory inspections.
• Experience leading investigations, root-cause analysis and process improvements.
• Proficient in risk management and quality data analysis.

Responsibilities

• Lead the maintenance and improvement of the Quality Management System (QMS) per IVDR/ISO 13485.
• Drive development and optimization of quality system procedures and controls.
• Lead quality activities across the product lifecycle including design, development, transfer, manufacturing and post-market.
• Provide expertise for change control, documentation review, validation protocols, and technical reports.
• Lead internal audits and represent QA in regulatory inspections and supplier audits.
• Mentor junior Quality Engineers and deliver quality training.
• Promote a culture of quality, compliance and continuous improvement.

Skills

IVDR knowledge

ISO 13485

CAPA systems

Validation processes

Internal auditing

Regulatory inspections

Statistical analysis

Quality improvement

Root cause analysis

Risk management

Education

Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Quality Management, or related

Tools

eQMS

Job description

Trinity Biotech is seeking a Senior Quality Engineer to lead the development, maintenance and improvement of the Quality Management System in line with IVDR (EU 2017/746) and ISO 13485.

You will partner with R&D, Manufacturing, Regulatory Affairs, and suppliers to ensure product quality, regulatory compliance and lifecycle excellence, leading investigations, CAPA, risk management and audits.