QA Design Specialist

Dormont Manufacturing Co; Ängelholms kommun; On-site; SEK 450,000 - 600,000; Full time

Job summary

Dormont Manufacturing Co is looking for a Quality Assurance Design Specialist to join their team in Ängelholm, Sweden. This role is crucial for ensuring compliance with design control and product life cycle management, working closely with R&D, operations, and regulatory affairs.

The ideal candidate will have a University Degree in Science or Technology and experience in document control and risk management. Proficiency in English is required, and fluency in Swedish is preferred. Enjoy a collaborative environment where every voice matters.

Qualifications

• One year of experience with document control, change control, and risk management activities.
• Strong understanding of ISO 13485, ISO 14971, FDA 21 CFR Part 820, IVDR.
• Ability to work effectively with R&D, operations, and regulatory affairs.

Responsibilities

• Ensure implementation of design control processes across new product development.
• Collaborate closely with stakeholders for quality assurance throughout the development process.
• Maintain document control processes for quality and technical documentation.

Skills

Document control

Change control

Risk management

Communication skills

Problem-solving skills

Fluent English

Fluent Swedish

Education

University Degree in Science, Technology or equivalent

Job description

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. Care is the bedrock upon which we stand. It’s manifested in our devices, our people and how we interact with the world.

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.
• One year 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.
• Good communication skills, excellent problem‑solving skills and fast adaptability to change.

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

• Design control.

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.

For more information, visit www.danaher.com