Quality Systems Engineer

Location: Penicuik, GB, EH26 0BF
Company: AliveDx

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 SYSTEMS ENGINEER
AliveDx is recruiting for a Quality Systems Engineer to join the Quality and Regulatory Affairs team based at our ARC site near Penicuik, EH26 0BF.

The role is a full-time, permanent position working 37.5 working hours.

Job Purpose
Reporting to the Head of QMS, the Quality Systems Engineer is responsible for managing and overseeing three foundational QMS processes: document control, change control and failure investigations. This includes ensuring the proper creation, revision, approval, distribution, and archiving all quality-related documents, facilitating the change control process from end to end and applying root cause analysis methodologies to failure investigations. The role plays a critical part in ensuring that all processes meet regulatory, customer, and internal requirements within the medical device industry.

YOUR MISSION
Your main responsibilities will include:

• Manage the document control system, including document creation, review, approval, distribution, and retrieval processes, in compliance with ISO 13485 requirements.
• Ensure that all documents are maintained according to the company's quality management system (QMS).
• Establish and enforce version control to maintain accurate and up-to-date documents.
• Manage the change control process; receive, log, evaluate and route engineering change requests.
• Chair change control board meetings and guide change.
• Manage product and process failure investigations.
• Ensure root cause analysis methodologies are being used and coach cross-functionally to ensure competency in root cause analysis.
• Support external audits.
• Ensure that all documentation is maintained in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Implement and maintain a secure system for archiving and retaining quality records according to regulatory and company retention policies.

YOUR COMPETENCIES

• Bachelor's degree in a related field (Quality Assurance, Life Sciences, Engineering) or equivalent experience.
• Minimum of 3 years of experience in a document control or quality assurance role within an ISO 13485 GMP or 21CFR part 820 -compliant environment, preferably in the medical device or pharmaceutical industry.
• Experience with document management systems and electronic quality management systems.

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 and access to marketplace discounts.

Closing date: May 21st 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