Quality Engineer

Key Responsibilities

• Review and assess validation, change control, risk analysis (e.g., FMEAs), software validation, and microbiological/sterilisation documentation.
• Support product development, new product introduction, and sustaining engineering activities through all stages of the lifecycle, including design controls and process validation.
• Partner with manufacturing and quality teams to ensure effective incoming, in-process, and final inspection processes.
• Lead CAPA activities and manage nonconformance investigations to ensure timely and effective resolution of quality issues.
• Support field-related quality activities, including assessments, investigations, and corrective actions.
• Participate in internal and external audits, representing the quality function and ensuring organisational readiness.
• Analyse quality metrics and performance data to identify trends, mitigate risks, and drive continuous improvement.
• Initiate and deliver improvement initiatives while mentoring junior team members and supporting team coordination.

Qualifications & Experience

• Degree in engineering, science, or a related technical discipline, with at least 3 years' relevant industry experience.
• Strong knowledge of regulatory requirements and standards (e.g., ISO, EU MDR, FDA).
• Proven experience in validation activities, including design, process, and software validation.
• Competency in statistical analysis and data-driven decision-making; additional quality or risk qualifications are advantageous.
• Strong communication skills, attention to detail, and ability to make independent, risk-based decisions in a regulated environment.