Quality Assurance Specialist
4 days ago
Ferrosan Medical Devices A/S is a leading company with a unique impact on global healthcare.
We are looking for skilled and dedicated professionals to join our Quality Control team in ensuring the highest quality standards of our medical devices.
Our products help surgeons and nurses control bleedings and avoid complications in surgical procedures.
The Quality Control laboratory at Ferrosan is responsible for analysis of raw materials, components, intermediates, and finished products.
We work according to GMP and ISO 13485, ensuring that our medical devices meet the highest safety and quality standards.
Your Role
As a Quality Control specialist, 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.
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
About You
We are looking for candidates with gathered QC experience, perhaps with some degree of specialization to their profile.
You thrive in a role offering a good balance of daily tasks and project work.
You are comfortable in an organization where specialists are not placed in a narrow silo, but often must take a broader scope.
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 spoken
We Offer
We offer a truly purpose-driven workplace where you can have real impact.
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.
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