Quality Manager – Devices & Software

Role Summary:
Responsible for quality assurance activities related to software and device development. Supports both new product development and sustaining projects in compliance with FDA and EU-MDR regulations.

Key Responsibilities:

• Serve as QA lead for design and development activities involving medical devices and embedded/application software.
• Apply design control principles throughout the development cycle.
• Review and approve documentation related to devices, software, and cybersecurity (e.g. validation plans, protocols, reports).
• Align with R&D, software, and systems teams to ensure coordination across technical groups.
• Participate in risk assessments (including CVSS scoring) and design reviews; ensure risks are addressed in accordance with standards.
• Provide QA input on software lifecycle processes, technical documentation, and engineering controls.
• Support quality system elements including:
  • CAPA
  • Non-conformance investigations
  • Internal and external audits
  • Change management and validation

Requirements:

• Bsc. in software / mechanical / biomedical / electronics, or similar fields.
• Minimum 5 years in QA roles for medical device/software development.
• Practical experience with:
  • Design and process validation
  • Change control systems
  • Software quality assurance activities
• Familiarity with applicable regulations and standards:
  • IEC 62304
  • IEC 60601
  • ISO 13485
  • 21 CFR Part 820
  • ISO 14971
  • EU-MDR
• Proficient in technical writing and verbal communication (English).
• Able to manage multiple projects and meet deadlines independently.