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.

QUALITY ENGINEER

AliveDx is recruiting for a Quality Engineer to join the Quality Systems team based near Penicuik, Edinburgh.  The role is a full-time permanent position, working 37.5 hours.

The Quality Systems Department is a part of the wider Quality group at Alba Bioscience, part of AliveDx, and its primary role is to ensure that all aspects of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) compliance are met through effective control of the Quality Management System (QMS).

The Quality Systems Department is responsible for the day-to-day management of QMS encompassing non-conformance management, corrective / preventive action, internal / external audit, change control and supplier management.

YOUR MISSION

Your main responsibilities will include:

• Have working knowledge of QMS concepts and procedures and perform a variety of routine tasks or assignments, including but not limited to:
• Non-conformance assessment and progression
• Change control assessment and progression.
• Quality meeting preparation and chairing

• Follow prescribed guidelines or procedures to provide solutions to problems such as:
• Root cause analysis
• Trending quality data from key data (e.g. non-conformance, CA/PA)

• Work with limited levels of guidance such that there is:
• Ownership of certain quality issues

• Continue to build knowledge of the business, processes and customers (internal and external):

• • Assist during internal/external audits from customers and regulatory bodies
  • Compile and contribute to specific quality metrics and trending accordingly
  • Identify areas for improvement and contribute to a culture of continuous improvement
  • Demonstrate and exhibit all key behaviours as defined by the business
  • Participate in an 'in-house' programme of continuous training and assessment

• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements including statutory Health & Safety legislation and internal practice.

YOUR COMPETENCIES

• Experience at an appropriate level in the Quality function of a business operating to cGMP.
• Understanding of QMS processes, i.e. Non-conformances / Change Controls / CAPA
• Effective time management and prioritisation skills. Ability to self-motivate and participate in team and project work
• Ability to work under pressure of a high workload, meet deadlines and respond flexibly

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: 30th September 2025

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.