QA Engineer, Corrective and Preventive Actions (CAPA) – Graduate Friendly job opportunity

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

Your new team

The QA team has a significant role in securing reliable and compliant products during production, storage and shipping of products. This is done by cooperating, supporting, facilitating, training and communicating towards obtaining the best results with partners in Supply Chain, Operations, Warehousing and supporting functions at the site in DK as well as the US and Polish production sites. The position is located in Denmark and reports to Director, QA Engineering and Operations. QA Engineering and Operations is a department with 19 employees divided into 3 teams, one of these is the CAPA team that you will join.

Develop your engineering skills in Radiometer’s QA team

Whether you have a background as an electrical, mechanical or another engineering background you can look forward to use your technical flair, curiosity and collaboration skills to investigate how to improve our development and production processes and thereby affect the quality of our products. You are the daily driver on CAPAs at the RMED site, understand when to open CAPAs, how to scope and how to document CAPAs and optimizes the process. Responsible for CAPA courses and CAPA Cafés were CAPA owners and Leads have direct sparring in how to write CAPAs.You will develop your understanding of how QA processes support and influence the business.

Responsibilities

• Collaborate with people in the organization to ensure continuous compliance to ISO 13485:2016 requirements and other relevant regulations and ensure efficient QA processes.
• Collaborating closely with Operations and R&D to ensure timely and compliant product deliveries.
• Follow up on CAPAs
• Support the Global CAPA Manager to optimize the CAPA process.
• Use a lean process view to constantly improve quality processes to become efficient, lean and in compliance with regulations.
• Participating in quality training activities.
• Keep updated knowledge of standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
• Providing guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.

We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect 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 is Tuesday 8 October, 2019

Start the application process by clicking "Apply Online" and follow the guidelines on our corporate career site. Please attach your CV and other relevant documents.If you fit the description, but still have questions, feel free to contact Radiometer’s Senior Recruiter, Peter Høgh, tel: +45 61 79 55 64We look forward to receiving your application.

Qualifications

The ideal candidate holds a M.Sc. or B.Sc. degree in engineering or similar. Good technical understanding and ability to learn the technical aspects of our products quickly and to communicate in a technical organization is important. This combined with most of the following increases your chances of success:

• Power and drive to ensure execution and results.
• Negotiation and change management skills.
• Presentation skills.
• Willingness to learn all about CAPA Management within Medical Devices
• Experience or practical knowledge about quality assurance for medical device products and components
• Broad process knowledge (production as well as R&D experience) preferred.

Nice to have:
• Knowledge of regulatory demands and standards: MDD/MDR, IVD/IVDR, ISO 13485, MDSAP, FDA legislation
• Work Experience of 1-3 years from other Medical Devices or IVD companies in a similar role
• Able to keep the overview in situations that requires quick decisions with a holistic view on Quality and Delivery.
• Experience with Stakeholder Management.
• Process optimization experience.

Danaher Corporation

OverviewDanaher 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.

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

Kilde: Jobnet.dk