QA Specialist, QMS Compliance, for a market leading Medical Device company in Brønshøj, Denmark at Radiometer

Date Posted: 5/8/2018

Job Snapshot

Job Description

Job ID: MED001508

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.

On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.


Want to know more about our mission and vision? Click on the link: Link of YouTube video




Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.


If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.


Description

We are proud of our focus and dedication to quality in Radiometer. We have a healthy focus on continually improving our way of working with quality documentation and we believe you will enjoy helping us develop even further in this area. 

Your new team
You report to the Director for Global QMS and your new team consists of you and 3 other QA Specialist. Besides your own team the QMS Compliance department also has a Customer Complaint Team with 6 people. The common denominator for both teams is that everyone has a great work ethic and enjoy the many tasks that has to be prioritized and handled with a high level of autonomy from each team member.   

Collaboration and communication are key elements in the quality agenda 
The QMS Compliance team has a significant cross-functional role in Radiometer globally as well as locally in Denmark where our more than 1,050 colleagues are located on the same site in Brønshøj making them very accessible. Our team is proud to contribute to the quality of Radiometer’s products and processes by cooperating, facilitating, training, and communicating with our 3,400 colleagues worldwide.

Your assignments
Your main responsibility is to drive optimization of the Quality Management System and support the organization locally as well as globally. You can expect to work with:

• Maintaining and supporting optimization of the Quality Management System. 
• Sharing knowledge and maintaining expertise within applicable standards and regulations.
• Document change control and focusing on increasing QMS compliance through training and coaching of colleagues contributing to the system
• Participating in projects in the RA/QA function
• Supporting the organization during External Audits.

The position does not require a lot of travelling but some days during the year can be expected.

Application deadline
Application deadline is Tuesday 22 May 2018. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents. We look forward to receiving your application.
For further information, please contact Director, QMS Compliance, Bonnie Sperling at tel. +45 2795 0485.

Job Requirements



Qualifications

Qualifications from Medical Device industry and fluency in Danish and English required
The preferred candidate holds a Master degree in Engineering, Pharmacy, Biology, Biochemistry, or similar. This combined with some or most of the following skills and experiences increases your chances of success in the job:

• Excellent knowledge of applicable standards and regulatory requirements (ISO 13485, IVD, MD directive, and FDA legislation). 
• Experience with internal auditing and audit follow-up.
• Excellent verbal and written communication skills in English and Danish. In our daily work, we speak Danish as well as English.
• Good stakeholder management skills and understanding of how we as a function impact the business



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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% over 20 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.