Senior QA Specialist (2580)

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 expanding our QA organisation again, and we are looking for 2 new great colleagues. We are a team of highly dedicated QA Specialists and technicians who support our Production and ensure compliance in our documentation.

At FeMD, we make a difference in surgical care area, 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 10 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 and CAPAs, qualification and validation of utilities and equipment 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 Mette Wolsing.

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

• Change Control
• Complaints
• NC’s (non-conformities) and CAPA’s (Corrective and Preventive Actions)
• Qualification and validation of QC equipment
• Supporting our product release process
• Sparring in FeMD regarding quality related matters
• Participating in minor operation projects
• Training 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 knowledge about ISO 13485, MDR and preferable 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 CAPA, Change control and Complaints
• Fluency in Danish and English, written and verbally.
• Quality, improvement - and want to succeed together mindset.
  

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. We take pride in having fun and we are looking for you.