QA Project Manager

Coloplast; Denmark; Hybrid; DKK 700,000 - 900,000; Full time

Job summary

Coloplast is seeking a QA Project Manager to advocate quality from ideation to market introduction. Based at our Humlebæk HQ, you’ll lead a core team across regulatory, production QA, process validation, biosafety, sterilization, and more, ensuring design control and regulatory compliance.

You should have a bachelor’s degree in Engineering or Pharmacy, 5+ years in medical devices or pharma QA/R&D, and fluent English. The role includes international travel ( Hungary ) and a hybrid work setup.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy or similar.
• Minimum 5 years of experience in the medical device or pharmaceutical industry within Quality Assurance and/or R&D.
• Experience with project management or desire to grow into it.
• Familiar with ISO13485 and US FDA demands.
• Speak and write English effortlessly.

Responsibilities

• Manage and guide quality specialists and ensure on-time project deliverables.
• Assess, manage and mitigate product and project risks.
• Ensure successful design transfer by collaborating with R&D, Pilot site and Production sites.
• Report to management on milestones, risks and issues.
• Review and approve relevant design control documentation.
• Optimize and update quality processes with stakeholders.

Skills

Communication

English

Education

Bachelor's degree in Engineering or Pharmacy

Job description

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. What’s more, we offer a great work-life balance and a myriad of career paths,” explains Director Quality Innovation, Troels Rasmussen.

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.

Even though we each work on our own projects, we also collaborate closely, sharing knowledge and helping each other achieve our goals. “And in addition to great colleagues within the team, you get to work with equally great colleagues from all areas of our organization, earning you a huge network within Coloplast,” says Troels.

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, sterilization, 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
• Optimize and update quality processes in collaboration with your team and other stakeholders

You should anticipate around 10-20 travel days per year, primarily to our production sites in Hungary. Also, you will have the option to work from home approximately 1 day a week, but probably no more than that, as it is crucial to remain accessible to your team and 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

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Coloplast Group - Holtedam 1 - Humlebaek - DK 3050 - Denmark