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 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.   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 role of the department is to ensure the quality systems and processes in place meet the requirements of GMP, assuring safe and effective product manufacture and delivery. In addition, the department is responsible for the preparation and maintenance of documentation related to materials and suppliers to enable the Company to comply with EN ISO 13485 and 21 CFR Part 820 regulations and to ensure ongoing regulatory compliance with the IVD Directive/Regulation and FDA regulations.

YOUR MISSION

Your main responsibilities will include:

• Has working knowledge of QMS concepts and procedures and performs a variety of routine tasks or assignments.
• Follows prescribed guidelines or procedures to provide solutions to problems eg root cause analysis.
• Continues to build knowledge of the business, processes and customers (internal and external): 
• Assist during internal/external audits from customers and regulatory bodies.
• 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.
• Perform any other duties as reasonably requested from the company from time to time.

YOUR COMPETENCIES

• A relevant degree or equivalent qualification, plus relevant work experience.
• 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
• Thorough understanding of core IT packages, particularly MS Excel and MS Word.
• Effective time management and prioritisation skills. Ability to self-motivate and participate in team and project work.

• Ability to analyse situations and processes to eliminate problems.

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.