Sterilization Quality Specialist
4 days ago
Ferrosan Medical Devices A/S develops and produces a portfolio of medical devices used in surgical care. Our products are designed to minimize bleeding challenges in surgery and electromechanical medical devices for performing breast biopsies. We are an international company with products registered in over 100 countries, marketed in collaboration with global medtech partners.
Our team is driven by improving patient outcomes and takes 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.
Job Description
We are seeking a Sterilization Quality Specialist to join our Quality Control team. As a Sterilization Quality Specialist, you will be responsible for daily support to development projects and operations together with the rest of the QC team. You will take on a broad and interesting role with regular contact with the on-site organisation and external partners supporting our on-site production in quality, sterilization, and microbiological issues. Daily tasks involve analyzing OOS on finished products and handling deviations and CAPAs. You will also represent QC in projects such as equipment qualification, analytical methods evaluation, and tasks related to compliance and optimizing processes e.g., reducing sampling sizes.
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, 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
About the Role
This is a unique opportunity to join a rapidly growing company where you can have real impact and a development curve that you can steepen at a pace that is suitable to you. We offer a truly purpose-driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. We care about each other, our environment, and our customers, and we win for patients with innovative high-quality solutions.
Required Skills and Qualifications
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 English, written and spoken
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