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Danaher Medical ApS

Global QA CAPA Specialist



Åkandevej 21, 2700 København, Danmark

ID: 2155157
Indrykket for 72 dage siden

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 for Radiometer is responsible for supporting CAPA owners in across the organization and ensure that CAPAs are executed and documented in compliance with ISO 13485 and FDA regulations.

You will also drive CAPA review board meetings with management and regularly report process metrics monitoring the health of the CAPA process.

To succeed in the role, you have a strong quality mindset, knowledge of the regulatory requirements and the ability to communicate with all levels of the organization. You have a talent for creating good relations and the ability to support a broad range of stakeholders at all levels. You can be an ambassador for the CAPA process and have the drive to continuously improve the process and share best practice with peers at other production sites.

With reference to the Senior Manager, Complaint Handling and CAPA you will join a team of highly skilled and engaged colleagues. The team has a significant cross-functional role in Radiometer globally regarding the complaint and CAPA processes and in driving cross functional QA projects. We cooperate, facilitate, train, and communicate to seek solutions by being close to our partners.

This position is in Brønshøj and will be a hybrid role.

In this role, you will have the opportunity to:

  • Manage the CAPA process by supporting CAPA owners and review and approve CAPAs
  • Represent the CAPA Process at audit
  • Chairman of CAPA review board
  • Chairman of the Global CAPA Coordinator board 
  • The essential requirements of the job include:

  • The preferred candidate holds a master’s degree in engineering, Pharmacy, Chemistry, or similar
  • Knowledge of applicable standards and regulatory requirements i.e., ISO 13485, FDA legislation
  • Experience working with CAPA preferably in non-conformity than in the change request
  • Excellent verbal and written communication skills in English. The position is working closely with the rest of the global organization.
  • Application

    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 30th April 2023. If you have questions, feel free to contact Senior Manager, Complaint Handling and CAPA, Dorte Larsen at [email protected] We look forward to seeing your application.

    We thank you for your interest. Please read our Applicant Data Privacy Notice carefully 


    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. 


    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 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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