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Danaher Corporation Quality System Specialist in Angelholm, Sweden

Quality System SpecialistTemporary 14 months

Do you want to make a difference by developing key lifesaving medical device products? In a truly global business who refuse to compromise when it comes to caring for people.

As a Quality System Specialist, you will work cross functionally within the HemoCue organization and support the organization with your expertise.

Your responsibilities

  • Maintenance of the Document Control Management process for HemoCue AB.

  • Designated user for RA/QA within the Document Control Management process.

  • Ensure that changes to the Quality Management System is controlled and adequately managed prior to implementation.

  • Ensure that nonconformities to the Business Management System are assessed and managed according to established BMS NCR process

  • Develop and maintain yearly GMP training for organization.

  • Develop and maintain introduction for new employees related to the IVD industry and HemoCue QMS.

  • Designated user for RA/QA within the Document Control Management process

  • Ensure that deviations from procedures and plans are reported to nearest manager within the RA/QA organization.

Qualifications

  • Minimum 5 years of experience from Quality and Regulatory Management

  • Proven good knowledge (experience or training) in EU IVD Directive, ISO 13485, US Quality System Regulation

  • Communication skills

  • Fluent in English and Swedish verbally and in writing

PersonalityAs a person you are a team-oriented, supportive, shows initiative and likes a fast pace. You find it easy to communicate with other people and enjoy working in a company that is driven by continuous improvement, both in terms of equipment and processes.

Interviews will be held as soon as relevant candidates have been identified

Send your application via www.hemocue.com/jobbsidan. We are not able to receive your application by other means than through “jobbsidan“. Please bring diplomas for face-to-face interviews. Any application by mail or e-mail will be returned.

We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Sweden and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development.

We are looking forward to receiving your application no later than February 28.

For further information, please contact Quality System Manager, Caroline Fundin at tel. +46 734 14 03 94.

Union contacts: Mikael Godolakis, Unionen, +46 431 48 14 66 or Elin Söderlind, Akademikerföreningen, +46 431 48 12 62.

About Danaher

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries. A globally diverse team of 71,000 associates, we are united by our culture and operating system, the Danaher Business System, which is our competitive advantage. In 2014, we generated $19.9B in revenue and our market cap exceeded $60B. We are #149 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 2,000% over 20yrs.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

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