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Do you want to ensure quality products for people with intimate health care needs? And would you like to play a hand in the development of new innovative products? Then grab this opportunity to make your QA experience count as you work with products from initial idea all the way to market introduction. You will be the advocate for quality in our products, giving you a lot of impact. Take centre stage at the heart of global quality. Joining Quality Innovation at our HQ in Humlebæk, you are welcomed by 11 fellow QA Project Managers with different levels of experience and various nationalities. Our task is to make sure that when new products are introduced to the markets, they are compliant and of the best possible quality for the user. The products we work with range across ostomy, continence, wound and skin care but also include electronics and embedded software solutions for medical devices. As a QA Project Manager, you will participate in innovation projects as the quality representative, being accountable for the quality deliverables of the project. Thus, you will ensure product quality across design control processes, regulatory compliance and production. Doing so, you will manage a core team of specialists within regulatory, production QA, process validation, biosafety, sterilization, supplier quality, shelf life, transportation testing, labelling and vigilance. Just as you will network and coordinate activities across a wide range of stakeholders.
Job Responsibility:
Manage and guide quality specialists and ensure on-time project deliverables
Assess, manage and mitigate product and project risks
Ensure successful design transfer by continuously collaborating with stakeholders in R&D, Pilot site and Production sites
Report to the GQRAS Management team on project milestones, risks and issues
Review and approve relevant design control documentation
Optimize and update quality processes in collaboration with your team and other stakeholders
Requirements:
Relevant academic background, minimum a bachelor’s degree in e.g. Engineering, Pharmacy or similar
Minimum of 5 years of experience from the medical device- or pharmaceutical industry within Quality Assurance and/or R&D
Experience with project management – alternatively, the skills and interests to become a great project manager
Familiar with ISO13485 and US FDA demands
Speak and write English effortlessly
What we offer:
Great work-life balance
A myriad of career paths
Option to work from home approximately 1 day a week