Arbejde QA Professional – R&D Project Development Partner unspecified RADIOMETER MEDICAL ApS - jobtilbud
reference: 4952499
documentId: 4952499
connectionPointId: 7
lastModificationDate: 1551429736543
stillingsbetegnelse:
QA Professional – R&D Project Development Partner
jobbeskrivelse:
Description
The level of capabilities within engineering and natural science is high in Radiometer. We enjoy working with the multi-disciplinary product design processes as our products combine mechanical, electrical (hardware and software) and chemical aspects among others. Helping caregivers make diagnostic decisions that save lives motivates us to ensure that we in QA always develop our capabilities and contribution related to:
Risk Management
- Usability
- Requirements Management
- Systems Engineering
- Design Verification and Validation
- Design Planning
Partner with R&D for safe and reliable Medical Devices
The QA Engineering team has a significant role in ensuring safe, reliable and compliant products during new product development and maintenance of existing product platforms. We cooperate, guide, facilitate, train and communicate closely with R&D to ensure the best results.
The position is located in Denmark and is part of a team of six highly skilled engineers working with design control for Blood Gas, Transcutaneous monitoring and sterilized sampler products. As we have other international sites, expect to collaborate globally.
You report to the Senior Manager, QA Engineering, Claus Steen in Radiometer.
The privilege of involvement in several R&D Projects
QA Engineering is exciting as you help outline a project and how to get the necessary approval for the product development or product update. Whether it is changing a plastic component in a current design or considering future designs for microprocessors in our Medical Devices, you get to be involved in crucial collaborations and have meaningful discussions about documentation and technical designs.
Expect to get a unique insight in our complex systems and to collaborate with very skilled colleagues, who has a fascinating understanding of our products.
Responsibilities summed up
- Provide guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment
- Represent Quality Assurance in design and development projects and on cross-functional teams supporting new product development, agreeing and planning for requirement management and approving documentation
- Collaborating closely with R&D, Operations and Regulatory Affairs to assure high quality throughout the development process including design transfer and post launch activities
- Take part in the Quality assurance activities as an active member of relevant project teams
- Assessing overall product risk by facilitating the use of risk management tools and contributing to the risk management evaluations
- Participating in quality training activities
- Keep knowledge updated on standards, regulatory requirements and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
Travelling is expected to be at a limited level in the range of 5-10 days per year. Among other things, we offer the opportunity to go for a very relevant and highly respected Design Control training (AAMI Design Control Training), as part of your development plan with us.
Contribute, grow and develop
Developing on a personal and professional level is of a high importance for everyone in Radiometer and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher. As part of your employment, we offer a competitive salary package as well as a broad range of staff benefits.
Application deadline
Application deadline is Wednesday 20 March 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 Manager, QA Engineerng, Claus Steen at tel. +45 27770979.
Qualifications
The ideal candidate holds a M.Sc. or B.Sc. degree in engineering, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted. This combined with the following increases your chances of success in the job:
- QA or R&D experience from the medical device or IVD industry or other similar regulated industries
- Knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO and IVDR/MDR)
- Process development and lean thinking
- Structured person with skills for planning and visual management
- Drives process improvement projects forward to reach pivotal objectives and makes things happen and follows through.
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 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% 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.
Organization: Radiometer
Job Function: Engineering
Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule: Full-time
numberOfPosts: 1
jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2421
abstractJV_contact_0: Please apply using one of the specified channels
positionTypeCode: directhire
contractTypeCodes_0: fulltime
Arbejdsgiver Navn: RADIOMETER MEDICAL ApS
source: DK-STAR
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