QA Design Specialist

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

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Together with Danaher’s 15+ other operating companies, we unlock the transformative potential of cutting-edge science and technology to improve billions of lives every day. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. HemoCue is a leading provider of point-of-care diagnostic solutions, enabling healthcare practitioners across clinical settings and geographies to improve patient outcomes and clinical workflows. For more than four decades we’ve been advancing what’s possible at the point of care. HemoCue offers point-of-care testing for hemoglobin, glucose and HbA1c as well as total and differential white blood cell count. The role Quality Assurance Design Specialist for HemoCue is responsible for Design control and risk management activities. The QA Design Specialist ensures that procedures and activities related to Design Control and Product Life Cycle Management processes are in compliance with requirements in applicable regulations and standards (e.g. ISO 13485, IVDR, ISO 14971 etc.) as well as with industry best practice. You will be a part of the Quality Assurance Design team at RAQA and report to the Manager, QA Design. This position is part of the RAQA department, located at HemoCue HQ, in Ängelholm, Sweden and will be on-site. At HemoCue, our purpose is clear: advancing care, test by test, everywhere. If you thrive in a caring, multifunctional, fastpaced and supportive environment and want to work to build a world-class RAQA organization continue reading.

In This Role, You Will Have The Opportunity To

• Ensure effective implementation of design control processes across new product development, including design planning, design reviews, verification and validation.


• Collaborate closely with stakeholders to ensure high quality throughout the development process including design transfer and post launch activities


• Maintain robust document control processes, ensuring controlled creation, approval and change management of quality and technical documentation


• Act as a resource within the RAQA Team supporting additional tasks based on operational needs

The Essential Requirements Of The Job Include

• University Degree in Science, Technology or equivalent


• Five years of experience working with document control, change control and risk management activities.


• Strong understanding of applicable standards and regulations, including ISO 13485, ISO 14971, FDA 21 CFR Part 820, and IVDR.


• English – fluent verbally and in writing, and preferable Swedish – fluent verbally and in writing


• Ability to work effectively with R&D, operations and regulatory affairs.

It would be a plus if you also possess previous experience in:

• Good communication skills


• Excellent problem-solving skills


• Fast adaptability to change

Join a winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

Union contacts: Grgur Jamičić, Akademikerföreningen, [phone]

For more information, visit www.danaher.com.