QA Specialist with ISO13485 - and distributor handling experience in Brønshøj, Denmark at Radiometer

Date Posted: 7/3/2019

Job Snapshot

Job Description

Job ID: MED001794

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

Radiometer’s products are distributed globally and we collaborate with many different distributors worldwide. Our collaboration is based on good quality, which is why we are looking for an additional colleague in the team, who can focus on the quality demands for our distributors. With a sound knowledge of ISO 13485 and passion for global collaboration we know that you can be a great addition to the team. 
You join the QA specialist team within Supplier and distribution Quality Management in Brønshøj and take part in our mission to ensure that our products are distributed in compliance with our quality requirements. 

Help the Distributors evaluate their quality
Collaborating with Global Sales and Global Supply Chain you secure the procedures and documentation to help our distributors live up to our quality demands. With more than 100 distributors we have a clear mission of maintaining, adjusting and adding quality demands to ensure the successful collaboration with our distributors: 

The distributor Quality responsibility includes:
• Create an overview of the 100+ distributors 
• Ensure the correct treatment of our products (E.g. Cool chains, change notifications and vigilance) 
• Desk audits performed with a suiting interval ensuring the distributors capability to fulfill Radiometers quality requirement
• Plan and perform audit of the critical distributors based on the desk audit and questionnaire evaluation
• Ensuring compliance of the Quality Management appendix in the Distributor  agreement  
• Maintain the SOP for distributor collaboration in cooperation with Global Sales and Global Supply Chain

Your systematic overview and ability to trend on data will ensure that we identify potential countermeasures that will ensure that our customers get the right quality of products delivered on time. A vital focus based on our values related to Quality First Always and Superior Customer Experiences. We can’t wait for you to contribute to this important mission.

We offer you
A unique opportunity to work in the field of medical technology, where knowledge sharing and professionalism combine to make it both fun and meaningful to go to work. Both in Denmark 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, and a wide range of staff benefits. 

Application deadline
Application deadline is Wednesday 31 July 2019. 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. If you have any questions to the recruitment process, you are welcome to contact Recruitment Coordinator, Birgitte Scheel Andsersen, +45 2795 0482.

Job Requirements



Qualifications

Systematic QA specialist 
Passionate about quality and highly independent in your work, you are ready to take on own responsibility and make decisions that may influence the final product and potentially the lives of consumers worldwide. 

You also:
• Possess 2-4 years of experience with QA and from the Medical Device, IVD, pharma or similar regulated industries – Knowledge about distribution
• Lead Auditor or experienced with audit 
• Have an engineering or pharmaceutical degree
• Preferably, have knowledge of ISO 13485:2016, FDA QSR and MDSAP
• Are able to travel up to 30 days per year
• Speak and write English fluently



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.