QA Operations Specialist

HemoCue; Ängelholms kommun; On-site; SEK 420,000 - 560,000; Full time

Job summary

HemoCue, a leading provider of point-of-care diagnostic solutions, is seeking a QA Operation Specialist to ensure continuity in supplier quality management within RAQA. This on-site role at HemoCue HQ in Ängelholm collaborates with Operations, Quality Control and other functions to uphold quality across the organization.

You will support supplier qualification, audits, deviations and CAPAs, contribute to maintenance of the Quality Management System and participate in internal audits and

Qualifications

• Experience in QA, preferably including Supplier Quality.
• Basic understanding of regulatory requirements – GMP, ISO 13485, ISO 27001.
• Experience working with QMS is an advantage.
• Strong analytical skills and a structured way of working.

Responsibilities

• Support supplier qualification, evaluation and monitoring activities.
• Plan, conduct and follow up on supplier audits.
• Manage supplier-related deviations, complaints and CAPAs.
• Support day-to-day QA activities across the organization.
• Contribute to 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.
• Support QA Release activities and act as QA Release Specialist when qualified and authorized.

Skills

QA experience

Regulatory understanding

Analytical skills

Bilingual English/Swedish

Education

University degree in life sciences/engineering

Tools

QMS

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 QA Operation Specialist for HemoCue is 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 support supplier quality activities while also serving as a QA function collaborating with Operations, Quality Control and other functions across the organization. The role combines supplier quality management with operational quality assurance and offers a varied and developing work environment.

In this role, you will have the opportunity to

• Support supplier qualification, evaluation and monitoring activities
• Plan, conduct and follow up on supplier audits
• Manage supplier-related deviations, complaints and CAPAs
• Support day‑to‑day QA activities across the organization
• Contribute to 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
• Support QA Release activities and act as QA Release Specialist when qualified and authorized

The Essential Requirements Of The Job Include

• University degree in a relevant field (e.g. life sciences, engineering or equivalent)
• Experience in QA, preferably including Supplier Quality
• Basic understanding of regulatory requirements – GMP, ISO 13485, ISO 27001
• Experience working with QMS is an advantage
• Strong analytical skills and a structured 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 environmentOpportunities for professional development

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.

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.