QA Operations Specialist

Bring more to life.

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

At Radiometer, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

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.

At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

Learn about the Danaher Business System which makes everything possible.

The QA Operations Specialis t is responsible for ensuring that products and their associated documentation meet safety, quality, and compliance standards. This is achieved through close collaboration with and guidance of partners across Operations and R&D.

This position reports to the Senior Manager of QA Operations Manufacturing and is part of our dedicated QA Operations Manufacturing Team located in Brønshøj, Copenhagen and will be an on-site role .

In this role, you will have the opportunity to:

• Join a dynamic and cohesive team of six dedicated colleagues, fostering a culture of collaboration, open dialogue, and mutual trust, where your contributions are valued and recognized.
• Work closely with our colleagues in operations and R&D to ensure compliant and efficient nonconformance handling, production process risk analysis and Engineering Change Orders.
• Work with advanced medical device technology that combines chemistry, electronics, machinery, and software.
• Improve and optimize QMS processes that have a large impact on the organization.
• Participate in problem solving, improvement activities and R&D projects representing QA Operations Manufacturing.
• Provide general compliance guidance for our colleagues in operations.

The essential requirements of the job include:

• Fluent in Danish and English (spoken and written)
• Bachelor’s or master’s degree in a technical field such as electrical engineering, chemical engineering, mechanical engineering, chemistry, biochemistry, etc.
• A minimum of 3 years in medical device or pharma manufacturing in a QA, operations, R&D or regulatory affairs role.
• Experience writing technical protocols/reports or procedures/instructions.
• Great interpersonal skills are required as you will be interacting with various levels of the organization in a dynamic environment.

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

• Risk Management for Medical Devices (ISO 14791)
• LEAN methodology (5S, kaizen, value stream mapping, standard work
• Statistical methods for production eg. CpK or AQL

Application
We review applications on an ongoing basis and encourage you to submit yours as soon as possible.

Please note that response times may be longer due to the summer holiday period.
We look forward to hearing from you.

Radiometer, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

Check out our benefits at Danaher Benefits Info .

At Radiometer, we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

Danaher

Join our 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.

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Placering
Bronshoj, Denmark, state: , cityCountry: Bronshoj, Denmark