QA Operations Specialist

Om jobbet

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.

TheQA Operation Specialist for HemoCueis a role with combined responsibility to ensure continuity in supplier quality management with broad support across our RAQA function.

This position is part of the RA/QA department located at HemoCue HQ in Ängelholm and will be an on-site based role. 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.

You will be a part of the QA Operations team and report to the Manager QA Operations. In this position, you will play a key role in ensuring quality across our operations. You will take ownership of supplier quality activities. Also supporting internal QA function with collaboration within the organization.

In this role, you will have the opportunity to:

• Support the qualifications, evaluation and ongoing monitoring of suppliers to ensure compliance with quality requirements and applicable regulations
• Plan, conduct and follow up on supplier audits
• Manage supplier-related deviations, complaints and CAPA activities
• Support day-to-day Quality Assurance, including handling of non-conformities, and participation in QA Release activities
• Contribute to the maintenance and improvement of the Quality Management System
• Participate in internal audits and regulatory inspections
• Review and approve quality documentation
• Support training activities and ensure process compliance
• Contribute to change control and risk management processes

The essential requirements of the job include:

• A university degree in a relevant field (e.g. life sciences, engineering or equivalent)
• A few years of experience in Quality Assurance, preferably including Supplier Quality
• A solid understanding of regulatory requirements - GMP, ISO 13485, ISO 27001
• Experience working with Quality Management System is considered a strong advantage
• Strong analytical skills and a structured, detail-oriented way of working
• Fluent in English and Swedish, both written and spoken

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

• Flexible and comfortable working in a broad, varied role
• Strong communication and collaboration skills
• Self-driven with a high level of accountability
• Detail-oriented with a strong quality mindset

What we offer

• A broad and developing role within RAQA
• Opportunity to influence and improve quality processes
• A collaborative and knowledge-driven work environment
• Opportunities for professional development

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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.

For more information, visit www.danaher.com.