Senior QM R&D Specialist

2 months ago

Ballerup, Denmark Ambu AS Full time

State:

Country: Germany

Business Area: Quality Assurance

Department: Global Quality Management R&D

Employment Type: Full-time

Are you passionate about quality? Do you have a strong background in the Quality Management Support of Medical Device development, especially in Medical Electrical Equipment? Do you want to be a key player in a global Quality Management R&D Team to ensure compliance, continuous improvement and drive global cutting edge R&D projects?

Then your next career move may be as a Senior QM R&D Specialist with Ambu.

We are looking for a Senior QM R&D Specialist who can expand our Global Quality Management R&D department. You will be part of and drive a strong quality culture where take charge, team up and stay true are our core values. You will be part of a growing team of 16 engineers, based in the HQ in Ballerup, Denmark and our R&D Site in Augsburg, Germany.

This position can be based out of either Ballerup or Augsburg.

Key responsibilities

As Senior QM R&D Specialist, you will get a varied working day in a dynamic organization where you get to influence Ambu’s processes as well as your own daily tasks and responsibilities.

Your main responsibilities will include:

  1. Drive global R&D project activities in the role as QM lead.
  2. Take ownership of and lead Risk Management activities within R&D projects.
  3. Act as Contact person related to requirements for basic safety and essential performance.
  4. Handling and monitoring of CAPA; Non-conformities; Planned Deviations.
  5. Participate in Notified Body audits and inspections by authorities.

Suggested candidate profile

Skills can be earned in different ways, however, we imagine your background entails:

  1. A relevant academic background, BSc / MSc.
  2. At least 5 years’ experience of working within a quality organization for Medical Devices.
  3. Demonstrated experience in IEC 60601.
  4. In depth knowledge of ISO 14971.
  5. In depth knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD.
  6. Ideally, knowledge in IEC 62304.
  7. Passion for quality and focus on QM business partnering with the organization.

As a person, you are outgoing, have a good business understanding and are confident in communicating quality requirements and facilitating effective implementation in a global organization.

It is important that you are self-driven, like to take the lead, and that you can work independently. You take pride in collaboration, and are open-minded and see possibilities even when daily life is dynamic and hectic.

Ambu is a global company and English is our corporate language, which requires that you communicate fluently in English.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

When to apply

As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so there is no need to hesitate.

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.

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