Quality Design Specialist

HemoCue, a Danaher company since April 2013, is a global leader in Hb point-of-care testing. In 1982, HemoCue AB (Ängelholm, Sweden), introduced the first accurate, near-patient hemoglobin test. We offer point-of-care tests for hemoglobin, glucose, urine albumin, HbA1c, total and differential white blood cell count. Further information available at www.hemocue.com
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.
You will be part of a QA team that today consists of nine people with different background and experience. The team is responsible for quality assurance and quality development activities within the core processes Supply Chain Management and Product Lifecycle Management. This includes QA expertise during product development, production and further development of the already released products and manufacturing processes, handling of non-conformities as well as the qualification, auditing and monitoring of suppliers.
As a QA Design Specialist, you will be working in a cross functional team with R&D, Operations and Marketing and provide QA expertise and guidance to ensure safe, reliable and compliant products during new product development and maintenance of existing products.
We offer you an exciting possibility to join our fantastic team creating tomorrows solutions for Point of Care testing making peoples life’s better.
Responsibilities
Core Team Member Quality in Development Project performing activities according to HemoCue’s Product Life Cycle Management process
Risk Coordinator in regard to review of risk analyses, plans and overall residual risk reports
Support the organization with Design Control expertise
Coordinate Quality Assurance activities related to Engineering Change Order process

Qualifications
To qualify for the position, you need experience from QA or R&D in Medical Device industry or a QA role with focus on supporting R&D with QA expertise in a regulated industry. In addition to this you need:
University degree in science or technology
Knowledge and trained in relevant standards and regulations (ISO 13485, ISO 14971)
Fluent in English in writing and speaking, Swedish skills is a plus

Experience within Usability Engineering, FDA Quality System Requirements, Software Validation and Cybersecurity and Project Management is a merit.
Personality
To succeed as a QA Design Specialist you need to be systematic and analytical you also need to value and enjoy good teamwork. Furthermore we believe that a can do attitude and ability to prioritize in a fast paced environment is key. You also enjoy working in a company that aims to continuously improve, 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/careers. We are not able to receive your application by other means than through “careers“. 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 combined makes it both fun and meaningful to go to work. You will meet enthusiastic colleagues in both Sweden and abroad 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.
The position is a full-time position with flexible location we can offer you an office space in either our head office in Ängelholm or in our brand-new satellite office in Lund.
We are looking forward to receiving your application no later than September 15, 2021.
For further information, please contact Director Quality Assurance, Ola Lindau ola.lindau@hemocue.se
Union contacts: Björn Bylander, Unionen +46 431 48 12 87 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. 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.
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