Senior QA Specialist

We are expanding our QA organisation, and we are looking for a new colleague who is passionate about Quality and Production of Medical Devices. We are a department of dedicated QA Specialists who support our projects and ensure compliance in our documentation.
 
In Ferrosan, 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
You will be part of our QA Business Support Team, consisting of 12 QA Specialists and Senior QA Specialists, allocated to projects including innovation projects, capacity projects and strategic QA/QC projects. You will refer to the Senior Manager for QA Business Support. We participate in projects both as quality and compliance experts to ensure compliance with the requirements for Class III Medical Devices.
 
Your role
As our Senior QA Specialist, you will impact on the future of our products by:
 

• Participating as core team member in projects ensuring that projects follow our development model and QMS from concept to implementation, are completed on time and in the right quality as an approver of documentation.
• Reviewing and approving design control documents, validation documents, change controls, non-conformities, CAPA’s and SOP’s ready for submission.
• Collaborating with your QA-colleagues and stakeholders within the area of e.g. updating SOP’s for own area for continuous improvements.
• Being a good and constructive sparring partner for the organisation regarding quality and compliance related matters, train colleagues in QA-processes and drive a Quality Mindset.
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In this role, you will be in contact with a great part of our organization and your main stakeholders will be our colleagues in Product Development and Operations.
 
About you
You have a proven track record from working within QA. You have knowledge about ISO 13485, MDR and preferably 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 gemba 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.
• Preferably +5 years of QA experience within the Medical Device or Pharma industry.
• Experience with design control e.g. verification, usability, biocompatibility, risk management, stability, requirements, design reviews, design transfer, labelling and validation.
• Statistical skills for qualification and validation.
• Experience with other disciplines within QA areas; CAPA, change control, deviations and complaints will be an advantage.
• Fluency in Danish and English, written and verbally.
• Quality, improvement - and a want-to-succeed-together mindset.
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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 September 10, 2024.

Questions? Feel free to contact us:
 
Elisabeth Kjærside Storm Nielsen
Senior Manager, QA Business Support
+45 26 46 21 35