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Danaher Corporation QA Specialist in Bronshoj, Denmark

We are looking for a person to join our QA Engineering team that plays a significant role in ensuring safe and reliable products. So do you want to be part of saving lives by ensuring reliable and high-quality products? Then we want you!

We work with very complex product design involving a variety of technical fields including chemistry, mechanics, electronics, and software. In this role, you will be exposed to all technical fields involved.

We are supporting design control for Radiometer Blood Gas product lines (this includes ABL, TCM, and Samplers) both in new product development and maintenance of existing product platforms. We also work with our QA Colleagues to support design control towards Immunoassays and IT System solutions. This is done by cooperating, supporting, facilitating, training, and communicating towards the best results with partners in R&D.

This role will be acting as a QA specialist within specific projects in product development. You will join our team located in Brønshøj, and we are a team with a highly skilled and experienced QA Specialist. The team is highly encouraging for each other.

Responsibilities

  • 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 multi-functional teams supporting new product development, agreeing and planning for requirement management, and approving documentation.

  • Collaborating closely with R&D, Operations, and RA 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 updated knowledge of standards, regulatory requirements, and directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.

Qualifications

  • Specialist in design control processes in one or more of the following areas: Risk Management, Usability, Requirement management, systems engineering and architecture, Validation and verification, Design planning.

  • QA Design Control experience from the medical device or IVD industry or other similar regulated industries.

  • In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe, and other key markets (FDA, ISO, MDR, IVDR, MDSAP, and MDD)

  • Process development and lean thinking.

  • A structured person with skills for planning and visual management.

Our offer

An outstanding 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 we have hardworking colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer 'freedom with responsibility', flexibility, opportunities for training and career development, and a plethora of staff benefits.

Application

We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. Any important questions regarding the position can be directed to the Talent Acquisition Partner David Lyngh at davia@radiometer.dk. #LI-DA1

Radiometer

In our line of work, life isn’t a given - it’s the ultimate goal!

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 +4100 colleagues across 37 countries are committed and dedicated to help realize life’s potential. Developing on a personal and professional level is of high importance for everyone here and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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