QA Project Manager

QA Project Manager

Coloplast

Humlebaek, Denmark

You advocate quality and help bring forward new products

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, sterilisation, supplier quality, shelf life, transportation testing, labelling and vigilance. Just as you will network and coordinate activities across a wide range of stakeholders.

Your tasks will be to:

• 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;
• Optimise and update quality processes in collaboration with your team and other stakeholders.

Hands-on QA experience and networking skills

Renowned for your effective communication skills, you confidently navigate interactions at both top management level and the production floor. At the same time, you have the ability to articulate complex concepts with ease, fostering understanding and inspiring others along the way.

Moreover, we imagine that you:

• Have a relevant academic background; Minimum a bachelor’s degree in e.g. Engineering, Pharmacy or similar;
• Have a minimum of 5 years of experience from the medical device- or pharmaceutical industry within Quality Assurance and/or R&D;
• You have experience with project management – alternatively, you have the skills and interests to become a great project manager;
• Are familiar with ISO13485 and US FDA demands;
• Speak and write English effortlessly.

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Denmark      Medical Devices      On-site      Quality Assurance      Coloplast