Regulatory Specialist for Sterilization and Microbiology
15 hours ago
Ferrosan Medical Devices A/S develops and produces a portfolio of medical devices used in surgical care. Our products help minimize bleeding challenges in surgery and perform breast biopsies.
Job DescriptionWe are seeking a Quality Control Specialist to join our team. As a Quality Control Specialist, you will be responsible for daily support to development projects and operations together with the rest of the QC team.
Key Responsibilities:- 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, and monitoring of sterilization
- Contact with external collaborators and participation 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
To be successful in this role, you will need:
- 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 the production of sterile products would be an advantage
- Fluency in Danish and English, written and spoken
We offer a purpose-driven workplace where you can have real impact and a development curve that you can steepen at a 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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