Ambu A/S

Senior QM R&D Engineer I

Ambu A/S  •  Onsite  •  2 days ago
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Job Description

Responsibilities:

  • Participate in new product development and project design change for global products.
  • Participate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements and quality
  • Handle change control, especially be the expert in process validation for global products.
  • Participate in the critical quality issue which required QAE attention in the project as required.
  • Involve in NCR/ CAPA activities as required.
  • Maintain the Risk Management files and initiate Process Risk Evaluation during new platform project/ design change.
  • Other QM R&D function, as identified.

Requirements:

  • Degree in science or equivalent.
  • Min 2 years in Quality Assurance or Quality Engineering.
  • Knowledge in ISO13485 and ISO14971.
  • Experience in product development, project management and/or design control.
  • Innovative, committed with good accountability.
Ambu A/S

About Ambu A/S

Innovations that make a difference

Ever since 1937, Ambu has been rethinking medical solutions to save lives and improve patient care. Millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia and patient monitoring solutions.

In the past, we provided a way to maintain or restore breathing in any environment with the world’s first self-inflating resuscitator, the Ambu® Bag™, which is still in use today. More recently, we responded to a need for an endoscopy solution that is always available. The result? Ambu® aScope™, the world’s first sterile, single-use flexible endoscope.

Today, we continue to collaborate with leading medical experts to deliver innovations that make a real difference to healthcare professionals and their patients.

At our headquarters in Copenhagen, Denmark, and around the world in Europe, North America and the Asia Pacific, 5,000+ team members keep Ambu moving forward.

For more information, please visit www.ambu.com

Industry
Manufacturing & Production
Company Size
1,001-5,000 employees
Headquarters
Ballerup, DK
Year Founded
1937
Website
ambu.com
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