Danaher Corporation QA Specialist in Bronshoj, Denmark
Are you interested in playing a vital part in bringing market-leading products to the market? Then this is your chance to join a highly skilled and cross-functional team!
We, the QA Operations team, have a significant role in securing reliable and compliant products. We work mainly during the design transfer process phase and late development, production, storage, and shipping of products. We achieve results by cooperating, supporting, facilitating, training and communicating, and aligning with partners. Our main partners are in the Supply Chain, Operations, Warehousing, and support functions at the site in DK, the US, and Poland. We do however also work closely together with R&D.
The team and department
The position is located in Denmark and reports to Director, QA Engineering, and Operations. QA Engineering and Operations is a department with 25 employees divided into 4 teams.
The problem-solving and countermeasures taken in the area have a severe impact on customer experience, product quality, and production efficiency. This position makes daily decisions that have a high impact on the business results.
Your responsibilities include but are not limited to:
Partnership with Operations and R&D in relation to quality actions and quality decisions (ie. CAPA handling or GMP/GDP training).
Build a comprehensive understanding of concepts and principles within your own area and knowledge of others. This entails requirements and best practices in applying solutions and understanding of the influence on business objectives.
Participate in R&D project development representing QA-OPS to ensure a robustness design transfer and timely and compliant product deliveries.
Representing Quality Assurance in daily operation tasks like Change Control, process validation, Production Process Risk Management, Design Control, problem-solving, and the like in own area. You will also participate in internal and external audits and quality training activities.
3+ years of QA experience from Medical Device/IVD production environment.
In-depth knowledge of relevant regulatory demands and standards: MDD/MDR, IVD/IVDR, ISO 13485, MDSAP, FDA legislation
Proven experience with Production Risk Management and transfer of new product designs to production.
Able to keep the overview in situations that require quick holistic quality decisions.
Lead optimization of Quality processes in Operation to support business drivers (on-time delivery, product quality, reduce rework/waste)
Solution-oriented timely approach to problem-solving and driving improvement actions forward, making things happen, and following through.
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 +3800 colleagues are committed and dedicated to helping realize life’s potential.
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.
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 firstname.lastname@example.org. #LI-DA1
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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .