Danaher Corporation Senior QA Specialist, QMS Compliance in Bronshoj, Denmark
In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Senior Specialist, Global QMS Compliance for Radiometer is responsible for ensuring that the QMS is maintained (acting as subject matter expert and administrator) in accordance with applicable standards and regulations, drive and optimize supporting processes, conduct internal audits, and support external audits.
With reference to the Manager, QMS Compliance, you are part of a team of highly skilled and engaged colleagues. QMS Compliance has a significant cross-functional role in Radiometer, in Denmark and globally at Radiometer Contract Manufacturers. We cooperate, facilitate, train, and communicate to seek solutions by being close to our partners.
To become successful, you must have a talent for creating good relations and facilitate improvement. You are an excellent team player but are confident in working on your own.
This is a unique opportunity for personal and professional development in a fast-paced and dynamic environment with a distinct respect for the individual. 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', and a wide range of staff benefits.
In this role, you will have the opportunity to:
Handling of QMS and supporting processes
Conduct Internal Audits
Guide the organization during External Audits
Share knowledge and maintain expertise within applicable standards and regulations
Plan, facilitate, conduct training of the organization
Participate in and drive smaller projects in the RA/QA function with manageable risks and resource requirements
The essential requirements of the job include:
The preferred candidate holds a master’s degree in Engineering, Pharmacy, Biology, Biochemistry, or similar
Profound knowledge of and experience on best practices with Quality Management System(s) within Medical Devices/Diagnostics
Min. 5 years of in-depth knowledge and experience with applicable standards and regulatory requirements (ISO 13485, IVD, MDD, and FDA legislation) from QA job function
Experience with Front Office / Back Office roles during external audits
As a person, you relate to the following:
Positive, open-minded, and proactive. Adds energy to the team by taking responsibility
Work well independently – receiving minimal guidance – as well as in teams. Acts as a resource for colleagues with less experience
Possesses excellent communication skills. Thrives on working together with people from different cultures
Explains difficult information and work to build consensus
Exercises judgment based on the analysis of multiple sources of information
Enjoys having cross-functional interaction and working in project teams
Focuses on targets and results. Able to handle and prioritize many projects and tasks at the same time, while keeping deadlines
Good analytical skills
Systematic, detail-oriented, and well-organized
At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.
We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application.
We encourage you to apply before end of business on 10th February. If you have questions, feel free to contact Manager, QMS Compliance, Mette Egstrand at firstname.lastname@example.org. We look forward to seeing your application.
We thank you for your interest. Please read our Applicant Data Privacy Notice carefully here. (https://www.danaher.com/sites/default/files/inline-files/danaher%20applicant%20privacy%20notice.pdf)
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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.