Quality Engineer

AliveDx is recruiting for a Quality Engineer to join the Post Market Quality team based near Penicuik, Edinburgh. The role is a full-time permanent position, working 37.5 hours. The ALBA Quality and Regulatory Affairs group comprises a number of smaller teams who together establish the Quality/Regulatory link between ALBA products and the end user. The Quality Engineer role is part of the Post Market Quality team, who are responsible for the management of Complaints, Post Market Surveillance (PMS) and Product Risk Management for all Alba Products.

Your Mission

• Record and manage customer complaints within the eQMS in compliance with internal procedures
• Lead and coordinate complaint investigations, including root cause analysis using recognised methodologies
• Review investigation reports and prepare customer communications ensuring clarity and regulatory suitability
• Carry out Risk Management activities throughout the product life-cycle in accordance with applicable regulations and standards
• Create new and maintain existing Product Risk Management Documentation to ensure ongoing compliance
• Carry out Post Market Surveillance (PMS) activities for Alba Bioscience products in adherence with the required schedules to ensure regulatory compliance
• Create and maintain PMS documentation in line with appropriate regulatory requirements (e.g. IVDR) and in accordance with the agreed PMS schedule (PMS Plan, PMS Report, PSUR, PMPF)
• Working knowledge of QMS concepts and procedures; performs a variety of routine tasks associated with Complaints, Risk and PMS
• Chair cross-functional meetings
• Support / participate in internal/external audits from customers and regulatory bodies
• Providing support, guidance and training as needed to fellow team members in the Post Market Quality Areas of expertise
• Maintains up-to-date knowledge of products and process within the business
• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements

Your Competencies

• Risk Management or Quality Systems/Engineering qualifications/training
• Science degree or equivalent qualification, or a relevant degree combined with appropriate industry experience
• Strong understanding of QMS processes, i.e. Customer Complaints, CAPA, change management
• Ability to analyse, trend and present quality data and PMS data in accordance with procedures
• Knowledge of root cause analysis techniques
• Professional and effective communicator with external and internal customers

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. Closing date: 28th February 2026. 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.