Senior Quality Engineer

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

Job Description for Senior Quality Engineer

Job Title: Senior Quality Engineer

Department: Quality Assurance

Reports To: Site Head of Quality

Position Summary

The Senior Quality Engineer is a highly experienced quality professional responsible for leading the development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with IVDR (EU 2017/746), ISO 13485, and other applicable regulatory requirements.

The role provides quality leadership across the organisation, partnering with R&D, Manufacturing, Operations, Supply Chain, Regulatory Affairs, and external suppliers to ensure product quality, regulatory compliance, and operational excellence throughout the product lifecycle. The Senior Quality Engineer acts as a technical expert in quality systems and risk management, drives complex investigations, leads quality improvement initiatives, and supports regulatory inspections and third-party audits. Supports the Management Representative and serves as their delegate in their absence.

Key Responsibilities

Quality Management Systems

• Lead the maintenance and continuous improvement of the Quality Management System (QMS) in accordance with IVDR, ISO 13485, and applicable regulatory requirements.
• Drive the development, implementation, and optimisation of quality system procedures, processes, and controls.
• Provide expert guidance on quality system requirements across the organisation.
• Support management reviews through the analysis of quality performance metrics and recommendations for improvement.

Product & Process Quality

• Lead quality activities throughout the product lifecycle, including design, development, technology transfer, manufacturing, and post-market activities.
• Ensure quality requirements are effectively integrated into product and process development activities.
• Provide quality oversight and approval of technical documentation, validation protocols, reports, specifications, and change controls.
• Support product launches and process improvement initiatives from a Quality perspective.
• Lead and facilitate risk management activities, including risk assessments, FMEA, hazard analysis, and risk-benefit evaluations.
• Ensure risk management documentation remains compliant and current throughout the product lifecycle.
• Provide expert support in the identification and mitigation of product and process risks.

CAPA & Investigations

• Lead complex investigations into non-conformances, deviations, customer complaints, audit findings, and quality events.
• Utilise structured problem-solving methodologies and statistical analysis tools to determine root cause.
• Drive effective CAPA implementation and verify the effectiveness of corrective and preventive actions.
• Identify recurring issues and implement sustainable systemic improvements.

Validation & Change Management

• Provide quality oversight for equipment, process, software, and cleaning validation activities.
• Review and approve validation documentation to ensure compliance with regulatory and internal requirements.
• Lead quality assessment activities relating to change management and process improvements.

Audit & Regulatory Compliance

• Plan, conduct, and lead internal audits in accordance with audit schedules and regulatory requirements.
• Serve as a key quality representative during Notified Body audits, regulatory inspections, customer audits, and supplier audits.
• Drive audit readiness activities and ensure timely closure of audit observations.
• Maintain awareness of changing regulatory requirements and industry best practices.
• Analyse quality data and trends to identify opportunities for improvement and drive measurable quality performance enhancements.
• Lead cross-functional quality improvement projects using risk-based and data-driven approaches.
• Mentor and coach junior Quality Engineers and Quality Assurance personnel.
• Deliver quality training and provide technical leadership across the business.
• Promote a culture of quality, compliance, and continuous improvement throughout the organisation.

Required Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Biotechnology, Quality Management, or a related discipline.
• Minimum 5-8 years' experience in a Quality Engineering or Quality Assurance role within the medical device, IVD, pharmaceutical, or other highly regulated industry.
• Strong working knowledge of:
• IVDR (EU 2017/746)
• ISO 13485
• CAPA systems
• Validation processes
• Internal auditing techniques
• Experience supporting external regulatory inspections and certification audits.
• Demonstrated experience leading complex investigations, root cause analysis, and process improvement initiatives.
• Strong understanding of manufacturing and quality control processes within a regulated environment.
• Experience using statistical analysis and quality improvement methodologies.

Preferred Qualifications

• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent quality certification.
• Experience in diagnostic medical devices or In Vitro Diagnostics (IVD).
• Familiarity with FDA 21 CFR Part 820 and global medical device regulations.
• Experience with electronic Quality Management Systems (eQMS).
• Technical leadership and decision-making capability.
• Strong analytical and problem-solving skills.
• Excellent investigation and root cause analysis abilities.
• Ability to influence and collaborate across multiple functions and organisational levels.
• Strong communication and stakeholder management skills.
• High attention to detail with a risk-based mindset.
• Results-oriented with a focus on continuous improvement and compliance excellence.
• Ability to manage multiple priorities in a dynamic, regulated environment.