Responsibilities
- Take full QA ownership of one product family (Skin, Heart, Tissue)
- Clear the backlog of open Medical Device Changes and establish a functioning change control cadence that keeps pace with the engineering team
- Embed QA into all relevant Engineering Epics
- Deliver an audit-ready design history file and technical documentation for your assigned product family
- Lead risk management activities in accordance with ISO 14971
- Own the full risk management lifecycle for your product family, from hazard identification through residual risk evaluation and benefit-risk analysis
- Drive design controls across the product lifecycle
- Own change management
- Ensure design changes are properly assessed, documented, reviewed, and approved in compliance with applicable regulations and internal procedures
- Coordinate design transfer
- Work closely with manufacturing QA Lead and Production Support technical documentation for regulatory submissions
- Lead continuous improvement initiatives
- Act as QA subject matter expert for internal and external audits
- Participate in post-market surveillance
- Identify design-related issues and coordinate corrective and preventive actions
Requirements
- BSc or MSc in engineering, biomedical engineering, systems engineering, physics, or equivalent technical discipline
- 5+ years of experience in the medical device industry with a focus on hardware, firmware, or electrical equipment
- Deep expertise in design controls and risk management
- Strong working knowledge of IEC 60601-1, IEC 62471, IEC 62304, I62366, and ISO 10993
- Systems engineering mindset
- Self-leading and decision-capable
- Fluent English (written and verbal) with strong project management and cross-functional coordination skills
- Genuine fluency with AI-driven workflows and modern digital tooling
Nice to Have
- Swedish language skills
- Experience with Notified Body interactions and regulatory submissions
- Audit experience, internal and external
- Background in high-growth technology companies or startups
- Knowledge of firmware development and embedded systems
- Active participation in medical device industry organisations or standards committees
Team
Structure: small, high-trust Quality & Regulatory team
Additional Information
- Genuine fluency with AI-driven workflows and modern digital tooling — eQMS, automation, and AI-assisted documentation are part of how you work, not add-ons
