Document Control Engineer — Medical Devices, ISO 13485

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

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.