QA Design Specialist (Medical Devices)

Location: On-site at HemoCue headquarters in Ängelholm, Sweden

Company

hirify.global’s HemoCue provides point-of-care diagnostic solutions for hemoglobin, glucose, HbA1c, and white blood cell testing.

What you will do

• Implement design control processes across new product development, including design planning, design reviews, verification, and validation.
• Collaborate with R&D, operations, and regulatory affairs throughout development, design transfer, and post-launch activities.
• Maintain document control processes for the creation, approval, and change management of quality and technical documentation.
• Support additional quality assurance and regulatory affairs activities based on operational needs.

Requirements

• University degree in science, technology, or an equivalent field.
• At least five years of experience with document control, change control, and risk management.
• Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, IVDR, and related requirements.
• Fluent English, both verbal and written, is required.
• Ability to work effectively with R&D, operations, and regulatory affairs.

Nice to have

• Fluent Swedish, verbally and in writing.
• Strong communication and problem-solving skills.
• Ability to adapt quickly to change.

Culture & Benefits

• Work in a multifunctional quality assurance and regulatory affairs environment.
• Contribute to the development of point-of-care diagnostic solutions.
• Be part of a continuous-improvement culture focused on advancing healthcare.