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Head of Global Quality Management Operations

Ambu A/S

Country: Denmark

Location: Ballerup, DK

City: Ballerup

Business Area: QA/RA

Employment type: Full-time

Are you excited by quality and compliance within the Medical Device industry? Are you a passionate people manager, keen to make your team grow and bloom? Do you want to be part of a pioneering Quality Management team, continuously setting the bar high in everything we do?

Then this might be your defining moment. Apply today and join us as Head of Global Quality Management Operations out of our HQ in Ballerup, Denmark!

Key responsibilities

In this role, you will lead a stellar team consisting of 8 talented QM professionals. Together, you will ensure quality and regulatory compliance of Ambu products and processes across the organization by continuously monitoring compliance via CA/PA, NCR etc.

This will include development and optimization of the Quality Management System and Processes within your team’s area of responsibility. Moreover, you will be accountable for the Quality Assurance Engineering inputs to supplier control has the right quality and fulfil the regulatory requirements.

Your main responsibilities will include:

  • Managing the QM Operations team – from people development to being a trusted sparring partner
  • Being responsible for Quality Measurement, Analysis and Improvements. Hereunder continuous surveillance and improvements of CA/PA, NCR, Planned Deviations, Delivery Stop and Complaint processes
  • Broad range of authority – from approval of Design Control documents, to supplier approvals and signing SQM Quality Agreements
  • Supplier Quality Management
  • Responsible for QAE Compliance & SQM participation in Audits. This includes Internal, Corporate and Supplier Audits according to Ambu Audit plans.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

  • Hvae a relevant academic background, BSc / MSc
  • Have at least 5-8 years’ experience of leading a quality organization within Medical Devices
  • Carry demonstrated experience with CAPAs, NCRs, SQM
  • Have strong knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD
  • Have a passion for quality and focus on QM business partnering with the organization

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

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Ambu A/S

Baltorpbakken 13, 2750 Ballerup

Ambu A/S er en dansk verdensomspændende virksomhed som udvikler, producerer og markedsfører medicinsk udstyr til hospitaler og redningstjenester.

We accept unsolicited job applications: Apply through our webpages

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