Arbetsbeskrivning

Bring more to life.

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

At HemoCue, 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.

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.

Learn about the Danaher Business System which makes everything possible.

The QA Release Specialist for HemoCue is responsible for release of finished goods and to secure that the finished goods are in compliance with our QMS and regulatory requirements. The QA Release Specialist will also collaborate with Operations regarding Nonconformances and QA Operations is the owner of the Nonconformance process.

This position reports to the Manager QA Operations and is part of the QA Operations within RAQA located in Ängelholm, Sweden and will be an on-site role.

You will be a part of the QA Operations and report to the responsible for that our finished goods are in compliance with our QMS and regulatory requirements. If you thrive in a multifunctional, developing and sometimes challenging role what have close collaboration with multiple functions within the organization and want to work to build a world-class QA Operations organization—read on.

In this role, you will have the opportunity to:

• Make sure that our finished goods are in compliance with our QMS and regulatory requirement and release them for shipping
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• Review and approve investigations, material dispositions and required actions regarding Nonconformances
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• Drive continuous improvements together with Operations
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• Cooperate closely with other functions within the organization

The essential requirements of the job include:

• Bachelor’s degree within science or technology or equivalent working experience
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• 2 years of Quality Assurance experience within Medical Device or similar industry
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• Knowledge and experience within IVDR/IVDD, ISO 13485, Quality System Regulations for Medical Devices and risk management for medical devices (ISO 14971)
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• Communication skills (verbal as well as in writing) in Swedish fluent and English moderate or fluent
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• Detail-oriented and able to work independently as well as within a team

Don't hesitate to send in your application as interviews are ongoing. We look forward to reviewing your application. Welcome!

HemoCue, 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.

Fackliga kontakter:

Unionen: Henrik Pommer, 0431–481244

Akademikerföreningen: Katarina Cooper, 0431–481302