Senior Quality Engineer

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

Senior Quality Engineer

AliveDx is recruiting for a Senior Quality Engineer to join the Regulatory Affairs and Quality Department based at our Allan Robb Campus near Penicuik, EH26 0BF. This is a permanent role with flexible working options, working up to 37.5 hours per week.

YOUR MISSION

Your main responsibilities will include:

• Ensure Product Risk Management Process is compliant with relevant Risk Management Regulations.
• Lead and/or support all types of Product Risk Management activities according to procedures in place.
• Ensure Product Risk Documentation is compliant with procedures in place
• Ensure Product Risk Management Process efficiency according to KPIs set-up.
• Develop additional Risk Assessment and Management tools as required to ensure ongoing compliance
• Act as a Risk Management Team Representative during Third Party Audit 
• Perform any other duties as reasonably requested from the company from time to time.

YOUR COMPETENCIES

• Science background is required, with experience in Quality.
• Risk management and human factor engineering awareness.
• Working knowledge and experience of ISO14971.
• Appropriate experience in a regulated (GMP/GLP) scientific environment.
• Experience in document preparation / controlled documentation or Quality Assurance.
• Experience of processing complex documents.
• Experience in product / process validation.

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable and a range of core and flexible benefits ranging from private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days and access to marketplace discounts.

Interested? We look forward to receiving your application.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.