QA Design Specialist in Nationwide Sweden at HemoCue America

Date Posted: 7/6/2019

Job Snapshot

Job Description

Job ID: HEM000599

About Us

HemoCue, acquired by Radiometer Medical ApS in April 2013, is a global leader in point-of-care testing. HemoCue AB (Ängelholm, Sweden), introduced in 1982 the first accurate, near-patient hemoglobin test. The company also sells point-of-care tests for glucose, urine albumin, HbA1c, total and differential white blood cell count. Further information, visit www.hemocue.com

Radiometer - Make an impact on life. The difference between life and death can be just a few minutes. Radiometer’s diagnostic equipment is of crucial importance to doctors all over the world in their effort to diagnose critically ill patients quickly and accurately. From biotech and software specialists to financial controllers and engineers, all 2500 colleagues are committed and dedicated in their effort to make an impact on the life of others with our high-quality solutions. Radiometer’s leading position in the market has been secured over the last 50 years. Together we continue to raise the bar in acute care and constantly develop in new areas. Radiometer has an annual turnover of more than DKK 3 billion and is owned by US-based Danaher Corporation.



Description

Our Quality Assurance department needs reinforcement, we are looking for a

QA Design Specialist

Do you want to make a difference by developing key lifesaving medical device products? Are you an energetic and organized person who looks for new challenges? Do you want to work for a truly global business who refuse to compromise when it comes to caring for people? If your answer is yes, you may be the candidate we are looking for!

You will be part of a QA team that today consists of seven 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 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.

The Job

To be successful, you must cooperate cross-functionally and provide your QA expertise by supporting, guiding, training and communicating towards the best result with your partners. Your responsibilities and tasks will include

  • Act as QA Core team member in Development Project performing activities according to HemoCue Product Life Cycle Management process

  • Ensure that procedures and activities related to Design Control are in compliance with requirements in ISO 13485 and QSR as well as with industry best practice

  • Assessing overall product risk by facilitating the use of risk management tools and contributing to the risk management evaluations

    Qualifications
    You have a University degree in science or technology (Master or Bachelor)

    Experience from the following areas is required

  • Minimum three years of 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   

  • Ensure that Design Changes (to product and manufacturing process) are planned and implemented according to the Engineering Change Control Procedure and relevant considerations are taken regarding quality and regulatory requirements

  • Knowledge and trained in relevant standards and regulations, QSR and specifically Design Control (QSR 820.30), ISO 13485, ISO 14971

  • You have strong communication skills and can motivate and inspire your colleagues, even when there are conflicting demands


    Good knowledge of Swedish and English in speech and writing are essential.

    Personality
    As a person you are a team player, efficient, structured and solution-oriented and who 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

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 June 30.

For further information, please contact Quality Assurance Manager, Anna Stegmark at tel. +46 431 48 15 50.

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



Job Requirements



Qualifications

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Danaher Corporation Overview

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, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
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 is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.