Document Control Engineer

AliveDx Suisse SA; Penicuik; On-site; GBP 80,000 - 100,000; Full time

Job summary

A medical diagnostics company located near Penicuik is seeking a Document Control Engineer. This full-time role involves managing the documentation system in compliance with ISO 13485 standards, ensuring all quality-related documents meet regulatory and internal requirements. Candidates must have 2-3 years of experience in a similar role and a relevant bachelor's degree, with fluency in French being a plus. The position offers a dynamic work environment and flexible benefits.

Benefits

Private medical cover

Life assurance

Flexible benefits

Experience days

Marketplace discounts

Qualifications

• 2-3 years of experience in a document control or quality assurance role.
• Experience in ISO 13485 GMP or 21CFR part 820 compliant environment.
• Fluency in French is beneficial.

Responsibilities

• Manage document control system according to ISO 13485 requirements.
• Collaborate to create and update SOPs and controlled documents.
• Conduct regular document audits for compliance.

Skills

Document management

Quality Assurance

ISO 13485 compliance

Regulatory knowledge

Collaboration

Fluency in French

Education

Bachelor's degree in a related field

Job description

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.

DOCUMENT CONTROL ENGINEER

AliveDx is recruiting for a Document Control 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 QMS Lead, the Document Control Engineer is responsible for managing and overseeing the company's documentation system in compliance with ISO 13485 standards. This includes ensuring the proper creation, revision, approval, distribution, and archiving of all quality‑related documents, as well as maintaining the integrity and security of controlled documentation to support the organization's quality management system (QMS). The role plays a critical part in ensuring that all documentation meets 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.
• Collaborate with department heads and subject matter experts to create and update standard operating procedures (SOPs), work instructions, forms, policies, and other controlled documents.
• Facilitate and coordinate document review and approval workflows, ensuring timely completion.
• 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.
• Conduct regular document audits to ensure compliance with company policies and regulatory requirements.

YOUR COMPETENCIES

• Bachelor's degree in a related field (Quality Assurance, Life Sciences, Engineering) or equivalent experience.
• Minimum of 2‑3 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.
• Fluency in French (would be beneficial) and English.

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: 7th 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.