Quality Control Specialist

1 day ago

Copenhagen, Copenhagen, Denmark Ferrosan Medical Devices AS Full time

Do you want to be a part of our Quality Control team in a successful company with a unique impact on global healthcare? Grab this opportunity to join a rapidly growing company, ready to invest in you. Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.
Every 2nd second, Ferrosan Medical Devices' products help surgeons and nurses control bleedings and avoid complications in surgical procedures. We make seconds count in surgical care And we need you on our team

Quality Control working within microbiology, sterilisation, and project participation
Quality Control (QC) is a team of 22 skilled and dedicated colleagues. The Specialists and Associated Manager of the QC lab are reporting to the QC Director. The QC laboratory is responsible for analysis of raw materials, components, intermediates, and finished products. Most of the analyses performed are microbiological and physical tests. The analytical results form the basis for the final release of our medical devices and combination products to the market. Consequently, we work according to GMP and ISO 13485.

QC also holds the responsibility for external sterilisation processes (γ- and e-beam-irradiation and ethylene oxide), environmental monitoring of production areas and stability studies. Further the QC team holds the microbial competences and supports operations and development within this area.
We are involved in daily operation as well as providing support for various product development projects and optimisation projects ensuring compliance both internally as well as with our external partner and subcontractors. We are responsible for stability studies on marketed products. Our work environment is very welcoming and characterised by team spirit and helpfulness, also in busy times.

Your role
Reporting to the QC Director 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. Daily tasks involve analysing OOS on finished products and handing 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 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
You have gathered QC experience, perhaps with some degree of specialization to your profile. You thrive in a role offering a good balance of daily tasks and project work. You are comfortable in an organisation, where specialists are not placed in a narrow silo, but often must take a broader scope. You have a quality mindset, but you also know when to be flexible and pragmatic to find solutions. You are comfortable sometimes taking decisions on the spot and you can work as part of team to find the best way forward.

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 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.

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 on August 31 latest. We will process the applications as we receive them.

Questions? Feel free to contact us:

Susanne Lindegaard
Director, Quality Control
+45 51 88 78 48

Lise Moesby
Principal QC Specialist
+45 25 44 83 07

We look forward to hearing from you.

Read more about us here . #J-18808-Ljbffr

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