Quality Engineer

Quality Engineer

We are a technology‑driven organization operating in the healthcare and diagnostics sector. Our work focuses on developing reliable testing solutions that support clinicians and organisations in delivering timely, high‑quality care. We partner with a broad range of healthcare and community‑focused groups, and we emphasise operational excellence, innovation, and a culture of continuous improvement. Our environment is mission‑focused, collaborative, and committed to maintaining the highest standards of product quality, safety, and regulatory compliance.

Our work spans partnerships with hospitals, clinics, universities, public health programs, and corporate health providers. We value bold thinking, collaboration, and a dedication to delivering exceptional quality in everything we do.

The Quality Engineer will play a key role within the engineering team, acting as the primary liaison to Quality Assurance and Regulatory Affairs. This position focuses on ensuring product and manufacturing quality through proactive oversight, investigation leadership, change management, and compliance support. You will lead quality improvement initiatives, drive root‑cause analysis, guide process validation activities, and ensure alignment with regulatory expectations.

Regular visits to external manufacturing partners are required.

This role is ideal for someone who thrives in a dynamic environment, enjoys solving complex technical problems, and is motivated by delivering safe, reliable products to market.

• Plan and execute process validation activities for existing and new diagnostic products.
• Ensure contract manufacturers meet all quality and performance requirements.
• Review and approve validation documentation.

• Lead root cause investigations for material, process, or product issues.
• Manage non-conformances, determine need for CAPA, and drive CAPA closure.
• Oversee complaint investigations and trending.
• Conduct data analysis to identify operational risks or improvement opportunities.

• Serve as a key liaison with contract manufacturers.
• Manage supplier corrective action requests (SCARs) and ensure timely closeout.
• Coordinate change management activities and maintain quality consistency across multiple manufacturing sites.
• Support internal and external quality audits.

• Develop and maintain risk management files, including pFMEAs and process documentation.
• Ensure quality requirements remain robust as manufacturing scales or processes are optimised.

• Bachelor's degree in engineering or equivalent experience in medical devices.
• Strong knowledge of process validation and change management.
• Experience with CAPA and non-conformance processes.
• Familiarity with supplier quality and corrective action systems.
• Risk management experience (e.g., FMEA).

• Experience in ISO 13485-regulated environments (FDA or EU).
• Design verification exposure.
• Material and process characterisation.
• Root cause analysis expertise.
• Experience with IVD or molecular diagnostic products.
• Understanding of PCR or sample preparation workflows.
• CAD skills (Solid Works preferred).
• Strong analytical and problem‑solving abilities, including KPI analysis.