On‑Site QA Design Specialist — Design Control & Risk

HemoCue; Ängelholms kommun; On-site; SEK 700,000 - 900,000; Full time

Job summary

HemoCue, part of Danaher’s RAQA, seeks a Quality Assurance Design Specialist to drive design control and risk management for next‑generation point‑of‑care diagnostics. The role is based on-site at HemoCue HQ in Ängelholm, Sweden, and reports to the QA Design Manager.

You will ensure compliance with ISO 13485, IVDR and related standards while collaborating with R&D, operations and regulatory affairs. You will maintain robust document control and support lifecycle processes, enabling high-quality

Qualifications

• University degree in science, technology or equivalent is required.
• Experience in document control, change control and risk management is essential.
• Strong understanding of ISO 13485, IVDR, FDA 21 CFR Part 820 and related regulations.

Responsibilities

• Implement design control activities across new product development, including planning, reviews, verification and validation.
• Collaborate with R&D, operations and regulatory affairs to ensure quality throughout development and post-launch.
• Maintain robust document control, ensuring controlled creation, approval and change management of quality and technical docs.
• Provide RAQA support and additional tasks as needed within the team.

Skills

Document control

Change control

Risk management

Regulatory compliance

Education

University Degree in Science/Technology

Tools

ISO 13485

IVDR

FDA 21 CFR Part 820

Job description

HemoCue, part of Danaher’s RAQA, seeks a Quality Assurance Design Specialist to drive design control and risk management for next‑generation point‑of‑care diagnostics. The role is based on-site at HemoCue HQ in Ängelholm, Sweden, and reports to the QA Design Manager.

You will ensure compliance with ISO 13485, IVDR and related standards while collaborating with R&D, operations and regulatory affairs. You will maintain robust document control and support lifecycle processes, enabling high-quality