jobapplier

QA Operations Specialist

Danaher

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.

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.

About Danaher

  • 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.
  • 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.
  • 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. ​ Union contacts: Grgur Jamičić, Akademikerföreningen, +46431481423 #LI-RF1 #LI-Onsite 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 .

Responsibilities

  • You will support supplier quality activities while also serving as an 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 quality activities, including qualification and monitoring, supplier audits, and resolution of 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

Requirements

  • The essential requirements of the job include: University degree in a relevant field (e.g. life sciences, engineering or equivalent)
  • 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

Preferred

  • Experience in QA, preferably including
  • Supplier Quality Basic understanding of regulatory requirements – GMP, ISO 13485, ISO 27001 Experience working with QMS is an advantage

Benefits

  • Strong analytical skills and a structured way of working
  • Fluent in English and Swedish, both written and spoken
  • 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
  • Join a winning team today.

Every job at Danaher