QA Specialist for Supplier Quality Management in Brønshøj, Denmark at Radiometer

Date Posted: 6/7/2019

Job Snapshot

Job Description

Job ID: MED001780

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 growing and changing. So are our needs for supply. Be a dedicated QA specialist and use your experience to help us revise and implement new QMS procedures for an even better Supplier Quality Management, SQM.

You will join the QA specialist team within Supplier Quality Management in Brønshøj and take part in our mission to ensure product supplies fulfil RMED specifications and quality requirements. 

Perform QA within SQM and develop new QA initiatives
Collaborating with Global Procurement team, production, R&D and many other functions in the organisation, you secure high quality and reliable products from our suppliers placed worldwide. Your mission is not only to perform QA on current suppliers, but also to partake in new supplier selection, approval, implementation and maintenance. To achieve this, you:

  • Plan and conduct system audit of the Quality Management System and process audit of the production at the current and new suppliers in accordance with ISO 13485:2016 and MDSAP 
  • Classify suppliers to ensure right focus depending on risks, challenges and opportunities
  • If required pre-approval of new supplier in form of e.g. a supplier visits
  • Implement and approve Quality Agreements
  • Follow-up on quality matters with suppliers 
  • Participate in develop new QA procedures within SQM together with the team and involved departments. The SQM area is under updating and there are great possibilities to contribute in optimizing the way of working and the QMS procedures
  • QA supplier quality evaluation meetings
  • Travel approximately 30-40 days per year to visit suppliers and perform audits

The supplier portfolio is broad and are within outsourced processes, outsourced services, contract manufactures and critical suppliers. 


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 Thursday 3 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.

For further information, please contact Senior Recruiter, Peter Høgh, +45 61 79 55 64 or QA Specialist Liselotte Siim at + 45 30 11 90 48.

Job Requirements



Qualifications

Experienced QA specialist with knowledge of production and R&D
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 5+ years of experience with QA, reliability and SQM in the Medical Device, IVD, pharma or similar regulated industries – preferably related to production, product quality and/ or R&D
  • Have an engineering or pharmaceutical degree
  • Preferably, have knowledge of ISO 13485:2016, FDA QSR and MDSAP
  • 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.