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 Manager QA - Product Development for Radiometer is responsible to provide guidance, review, and approval to the development of the quality practices and procedures that ensure device quality and compliance known as DESIGN CONTROLS.
This position is within the Quality Assurance Engineering department, reports to the Director of QA Engineering and is part of a QA-management team of 3 managers, one based in India.

In this role you will manage a team of 10 highly skilled engineers supporting QA activities within design control for Radiometer Blood Gas products.
The position includes maintenance activities for existing products and new development projects incl analyzers, SW, accessories, and sterilization. The team is responsible for training in QMS and assisting during audits and works closely together with our QA and RA teams in India and Poland.

The role requires to be based or relocate to the beautiful Copenhagen.
Once on site, we offer you the flexibility to work with a Hybrid model, working from home few days of the week, if you feel the need for it.

At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

If you thrive in a leadership role and want to work to build a world-class quality assurance organization—read on.

In this role, you will have the opportunity to:

• Manage, train, and develop the team and their personal and professional competencies. You will be responsible for performance objective planning, reviews, talent assessment, hiring, budgeting, and planning for the department.
• Represent Quality Assurance in design and development projects and on cross-functional teams supporting new product development.
• Collaborate closely with R&D, Operations and RA to assure high quality throughout the development process including design transfer and life-cycle management.
• Perform Quarterly detailed planning of project deliveries and commit to supporting projects as resources allow.
• Resource allocation and planning within the department and with relevant partners to ensure effective and timely handling of services as committed.
• Assess overall product design risk by facilitating the development of risk management tools and contributing to the risk management evaluations.
• Keep current on knowledge of standards, regulatory requirements, and directives applicable for MD /IVD and ensure relevant parts of the QA system are updated

The essential requirements of the job include:

• M.Sc. or B.Sc. degree in Chemistry or Engineering
  
• Proven experience managing highly skilled teams
  
• A past in Design Controls and possibly in R&D as well
• Proficient English
• In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA, ISO 13485, IVDR and MDR)
• Skills for planning and visual- and stakeholder- management
• Drive projects forward to reach pivotal objectives and makes things happen and follows through.

It would be a plus if you also possess previous experience in:

• IEC 62304

If you are interested, please apply with a CV in English.
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 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.

Placering
Bronshoj, Denmark, state: , cityCountry: Bronshoj, Denmark