Senior QA Specialist, Supplier Quality Management (2592)

Senior QA Specialist, Supplier Quality Management

Do you want to be a part of QA Business Support in a company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.   

Every 2nd second Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care! And we need you on our team! 

As a part of our team, you'll have the opportunity to contribute to a wide range of projects and tasks within the competencies of supplier quality management. Your role will contribute to driving improvements in our processes and in maintaining the top-quality services we deliver to our partners.

We are a diverse team of 15 QA Specialists ready to welcome you as the 3rd QA specialist working within Supplier Quality Management. In general, our team is a mix of ages, genders, and competences, working together to ensure compliance across the organization.

Your role 

As our Senior QA Specialist, you will impact on the future of our products by:

• Qualifying and approving new suppliers and participating in re-evaluation of the suppliers.
• Plan and conduct the supplier audits (process and systems audits) and is responsible for follow-up on audit findings.
• Drafting, approving and maintain Quality Agreements.
• Participating as team member in projects ensuring that projects deliverables in respect to suppliers are completed on time and in the right quality.
• Collaborating with your QA-colleagues, stakeholders in Operations and Supply Chain and suppliers within the area of Supplier Quality Management.
• Responsible for developing and maintain processes and systems within own area for continuously improvements.
• Acting as Subject Matter Expert for the supplier quality management area at both internal and external audits.
• Being a good and constructive sparring partner for the organisation regarding quality and compliance related matters with a Quality Mindset.
• Expect travel activities, app. 30 days per year.

In this role, you will be in contact with a great part of our organization and your main stakeholders will be our colleagues in Supply Chain, Product Development and Operations.

About you  

As a Senior QA Specialist, you will impact the relations to the company’s suppliers when working with Supplier Quality Management

We expect you to have:

• Experience with supplier audits within a medical device or pharmaceutical company.
• A bachelor’s or master’s degree in pharmacy, biology, engineering, chemistry, or similar.
• Experience with and passed training certificates of ISO13485 auditor, MDR and MDSAP.
• Certified Lead Auditor within ISO 13485:2016.
• Knowledge of production as well as R&D experience preferred.
• Interested in and motivated by working with systems, processes and navigating between daily business tasks and projects.
• Proven great stakeholder relationships.
• Fluency in Danish and English, written and verbal.

We offer a truly purpose driven workplace where you can have real impact 

We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.  

We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words. And we take pride in having fun 😊 

Some of the facts and a little piece of history  
Ferrosan Medical Devices develops and produces a portfolio of medical devices used in surgical care. Our portfolio consists of various hemostatic products to minimize bleeding challenges in surgery and electromechanical medical devices to perform breast biopsies. We are an international company with products registered in more than 100 countries. Our products are marketed in collaboration with global medtech partners. New ideas are developed and matured from the first thought to finished implementation in production. And we manage the business with an uncompromising focus on quality based on current GMP requirements. 

Want to join our team?  

Send your application along with your CV latest February 20th, 2025. We will process the applications as we receive them.  

Questions? Please do not hesitate to contact us:

Senior Manager, QA Business Support
Elisabeth K. Storm Nielsen
+45 26 46 21 35.   

We look forward to hearing from you.   

Read more about us here