Sterilization Specialist

6 days ago


Gladsaxe, Gladsaxe Municipality, Denmark FERROSAN MEDICAL DEVICES AS Full time
About Ferrosan Medical Devices

Ferrosan Medical Devices A/S is a leading manufacturer of medical devices used in surgical care. Our portfolio includes hemostatic products and electromechanical devices for breast biopsies, with products registered in over 100 countries.

Job Description:

We are seeking a highly skilled Sterilization Specialist to join our Quality Control team. In this role, you will be responsible for ensuring the quality and sterility of our medical devices.

Responsibilities:
  • Represent QC in product development projects, focusing on microbiology, sterilization, environmental monitoring, and design transfer to QC.
  • Support R&D and Operations within microbiology, endotoxin testing, and monitoring of sterilization.
  • Contact external collaborators and participate in audits.
  • Guide and support QC technicians.
  • Handle deviations, CAPAs, and changes.
  • Validate/verify microbial analytical methods and implement new methods in QC.
  • Prepare and maintain documents and instructions in the quality management system.
Requirements:

To be successful in this role, you will need:

  • Work experience from a similar role within pharma, medical device, or food industry.
  • A master's degree in pharmacy, biology, human biology, engineering, or similar field.
  • Practical experience with QC laboratory tasks.
  • Experience with microbial test methods, endotoxin testing, and other testing of sterile medical devices.
  • Strong knowledge of microbiological challenges and issues related to production of sterile products.
  • Fluency in English (written and spoken).
Salary and Benefits:

The estimated salary for this position is around DKK 550,000 - 650,000 per year, depending on experience and qualifications. We also offer a competitive benefits package, including health insurance, pension plan, and opportunities for professional growth and development.



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