Senior Manager, QA Engineering (Design Control)-MED001866

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 3800 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. DescriptionAre you driven by leading highly skilled employees and delivering high quality within QA? Then this role might be perfect for you. In this role and with this team at Radiometer we play an important role in securing reliable and compliant products during new product development and maintenance of existing product platforms. We do this by supporting, facilitating, and communicating to achieve the best results with partners in R&D.

Great team with QA expertise

The position is located in Denmark and you will be managing a team of 8 highly skilled QA specialists supporting design control internationally for our Blood Gas products including ABL-, TCM-, and sampler products. You'll have direct reports in Poland and Denmark and there are plans to expand the team.
This role reports to the Director of QA in Radiometer and you will part of a QA management team of 3 managers, where one of them is based in India.Besides managing the team which includes supporting and developing the team members you will also be involved in the strategic management decisions. Within these areas, you are responsible for executing performance objective planning, reviews, talent assessment, hiring, budgeting and planning for the department.
We provide guidance within regulation for medical devices where we are collaborating closely with R&D, Operations and RA to ensure we deliver high quality and compliance throughout the development process and life cycle management.People manager with QA experience

Our people

At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgment that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all +3500 colleagues are committed and dedicated to help realize life’s potential.If you seek to be part of a purpose, performance and value-driven organization whose mission and vision guide our every action, we are eager to hear from you.

Application deadline

The application deadline is Wednesday 27 November 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, Director, QA Engineering, Helle Bækmark Andersen at tel. +45 4817 0730.

Qualifications

We are looking for candidates with these attributes:
• QA Design Control experience from the medical device industry (at least 6 years) preferred
• In-depth knowledge of relevant standards and regulations in the USA, Canada, Asia, Europe and other key markets (FDA, ISO IVDR, and MDR)
• Experience with risk management, usability and software for medical devices, and sterilization
• A structured person with skills for planning and visual management
• Result orientated and strong on collaboration skills.
The ideal candidate holds an M.Sc. or B.Sc. degree in engineering or similar relevant university level.

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, 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.

Organization: Radiometer
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule: Full-time

Kilde: Jobnet.dk