Senior QA Specialist (2965)

Senior QA Specialist
If you are passionate about the quality and production of medical devices, you are the person we are looking for. We are looking for a new great colleague – and we are a team of highly dedicated QA Specialists and Technicians who support our Production and drive process optimizations.

At Ferrosan Medical Devices, we make a difference within surgical care, and we are ready to invest in you and will support your development and help you grow your own skills. Every 2nd second, Ferrosan Medical Devices’ products help surgeons and nurses control bleedings and avoid complications in surgical procedures. Our products make seconds count in surgical care - and we need you on our team to continue our successfully journey.

Our team
In QA Operations Support, we are 7 QA Specialists and QA Technicians with broad knowledge about quality requirements for Medical Devices. We participate in all aspects of support to our production and QC e.g., handling non-conformities, CAPA’s and product release. Furthermore, we participate in projects both as quality and compliance experts as well as ensuring that our documentation complies with the requirements for Class III Medical Devices.

You will refer to the Senior Manager for QA Operations Support, Anne Kofod Boel.

Your role
As our new Senior QA Specialist, you will drive the optimization of quality processes and participate in daily support to our production and QC and act as approver of documentation. This will include tasks within the following areas:

• Process ownership for NC’s (non-conformities) and CAPA’s (Corrective and Preventive Actions)
• Handling of NC’s (non-conformities) and CAPA’s, Change Control and Complaints
• Supporting our product release process
• Sparring in FeMD regarding quality related matters
• Participating in operation projects
• Drive quality mindset and training of colleagues in QA processes

In this role, you will be in contact with a great part of our organization and your main stakeholders will be our colleagues in our Production and QC.

About you
You have a proven track record from working within QA. You have experience with ISO 13485, MDR and the requirements covered by MDSAP. As our products are based on raw material from animal origin and are used at the operating theatre, experience working with Class III products is an advantage.

You are a strong communicator with good analytical skills. You thrive in a dynamic workplace, practice “Go Look See / Go To Gemba” and like to improve and align work processes. You are oriented towards reaching results and aiming to keep deadlines with high level of quality and compliance.

In short, you bring:

• A master’s degree within pharmacy, biology, engineering, chemistry or similar
• More than 5 years of QA experience within the Medical Device industry
• Experience with deviations, CAPA’s, Change control and Complaints
• Preferably experience within production oversight
• Fluency in Danish and English, written and verbally
• Quality, improvement - and want to succeed together mindset

We offer an exciting workplace where you can have real influence
We offer an exciting and challenging job and a workplace with strong 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 products. You will meet a Danish-rooted company growing in number of international colleagues and a way of working where hybrid, digital, learning, and innovation are keywords. And we take pride in having fun ??