QA Design Specialist
Danaher · Hemocue AB, Sweden
QualityFull-timeCompany career page
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Role summary
QA Design Specialist role at HemoCue, part of Danaher, focused on design control and risk management for point-of-care diagnostic devices. Ensures compliance with regulatory standards and industry best practices throughout product development lifecycle.
What they're looking for
- University degree in science, technology, or equivalent
- Five years of experience with document control, change control, and risk management
- Strong knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and IVDR
- Fluent English verbally and in writing; Swedish fluency preferred
- Ability to collaborate effectively with R&D, operations, and regulatory affairs teams
What you'll be doing
- Oversee design control process implementation across new product development phases including planning, reviews, verification, and validation
- Manage document control procedures including creation, approval, and change management of quality and technical documentation
- Partner with cross-functional stakeholders to maintain quality standards through design transfer and post-launch activities
- Support additional operational tasks within the RAQA team as needed
Privacy & handoff
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