Do you want to make a difference by developing key lifesaving medical device products? Are you an upbeat 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!
This is a position where you will develop the risk management process and utilize it in practice to provide direction to many different processes. You will focus on continuous cross functional collaboration between different functions within the company and with other Risk Specialists within Radiometer group. You will collaborate with clinical expertise on establishment of appropriate Patient Risk Assessment for issues potentially impacting users and patient outcomes, help applying the knowledge in use and development of products and production processes.
You will have the overall responsibility and work from start to finish with the whole implementation of risk management. The work will be to lead risk management related activities for existing and new devices. You will ensure that applicable personnel are trained and have needed knowledge in relevant Regulations and tools such as FMEA and FTA.
The position will also be a coordinating role where you will assign and prioritize tasks within the QA Design and risk team to ensure that set goals are fulfilled.
You will be part of the QA team and report to Director Quality Assurance.
- To be successful, you will collaborate cross-functionally and provide your expertise by supporting, guiding, training and communicating towards the best result with your partners. Your main responsibilities and tasks will include
- Develop and maintain the risk management process
- Train the organization and establish a support team of risk leaders to ensure the best support to projects and engineering change orders
- Facilitate and support the organization in risk assessments
- Ensure that procedures and activities related to risk management are in compliance with requirements in ISO 13485 and QSR as well as with industry standard methodology
- You have a University degree in science or technology (Master or Bachelor)
- Experience from the following areas is required
- Minimum three years of experience in Risk Management from medical device industry or similar
- Knowledge and trained in significant standards and regulations, QSR, ISO 13485, ISO 14971
- Knowledge in Design Control is an advantage
- You have strong interpersonal skills and can motivate and encourage your colleagues, even when there are conflicting demands
- Good knowledge in English in speech and writing are needed.
As a person you are a teammate, efficient and structured and who loves a fast pace. You find it easy to communicate with other people and enjoy working in an environment that is motivated 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
An outstanding opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and important to go to work. Both in Sweden and abroad you will meet hardworking colleagues who take pride in making a difference in a company whose products can truly have an effect on 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 August 30.
For further information, please contact Director Quality Assurance, 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.
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.