Quality Control Specialist

at  Ferrosan Medical Devices

Quality Control Specialist
Do you want to be a part of our Quality Control team in a successful 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!

YOUR ROLE

Reporting to the QC Director you will be responsible for daily support to development projects and operation together with the rest of the QC team. You will take on a broad and interesting role with regular contact to the on-site organisation and external partners supporting our on-site production in quality, sterilization, and microbiological issues. Daily tasks involve analysing OOS on finished products and handing deviations and CAPAs. You will also represent QC in projects such as equipment qualification, analytical methods evaluation and tasks related to compliance and optimizing processes e.g., reducing sampling sizes.

Your primary tasks cover:

• QC representative in product development projects in microbiology, sterilization, environmental monitoring and design transfer to QC
• Support to R&D and Operations within microbiology, endotoxin testing monitoring of sterilization
• Contact to external collaborators and participate in audits
• Guidance and support of QC technicians
• Handling deviations, CAPAs and changes
• Validation/verification of microbial analytical methods and implementation of new methods in QC
• Prepare and maintain documents and instructions in the quality management system

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.
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.

The role requires:

• Work experience from a similar role within pharma, medical device, or food
• A master’s degree within pharmacy, biology, human biology, engineering or similar
• Some years of practical experience with QC laboratory tasks
• Experience with microbial test methods, endotoxin testing, and other testing of sterile medical devices is a huge advantage
• Strong knowledge of microbiological challenges and issues related to production of sterile products would be an advantage
• Fluency in Danish and English, written and spoke