QARA Engineer - Medical Devices & Compliance Tools

Flok Health; Cambridge; Hybrid; GBP 45,000 - 60,000; Full time

Benefits offered by this job

Onsite gym

Digital health subscription

Desk setup allowance

Monthly team feasts

Job summary

Flok Health is seeking a QARA Engineer to enhance quality and regulatory processes in the development of high-quality medical devices. This role involves understanding ISO standards and improving processes through collaboration across teams in a dynamic work environment.

As the first dedicated QARA Engineer, you will have significant influence on operations. This position offers exciting opportunities to work at the intersection of technology and healthcare, with benefits including equity schemes and comprehensive medical coverage.

Qualifications

• Exposure to software-as-medical-device development is desired.
• Knowledge of ISO standards pertinent to medical devices.
• Ability to build internal tools for process improvements.

Responsibilities

• Design, implement and improve processes for ISO requirement compliance.
• Work with clinical, product, and engineering teams to resolve inefficiencies.
• Ensure technical file documentation is complete.

Skills

Understanding of ISO standards

Experience in software-as-medical-device development

Ability to work collaboratively

User-centric mindset

Job description

Flok Health is seeking a QARA Engineer to enhance quality and regulatory processes in the development of high-quality medical devices. This role involves understanding ISO standards and improving processes through collaboration across teams in a dynamic work environment.

As the first dedicated QARA Engineer, you will have significant influence on operations. This position offers exciting opportunities to work at the intersection of technology and healthcare, with benefits including equity schemes and comprehensive medical coverage.