Senior Quality Assurance Specialist (Product Development) – Ferrosan Medical Devices A/S

We are looking for a Senior QA Specialist, providing expertise in Product Development.

Do you want to be part of a strong QA department and be the QA representative in one of our strategically important product development projects?

Are you also looking for an independent role where you will set the direction and standards for compliance and quality in the product development project?

We are hiring a Senior QA Specialist wanting to join us on our journey.

About Ferrosan Medical Devices A/S

Ferrosan Medical Devices A/S develops and produces a portfolio of hemostatic products to aid surgery minimizing bleeding challenges SURGIFLO™, SPONGOSTAN™, SURGIFOAM®.  Products are registered as medical devices (Class III) and are sold internationally in more than 100 countries in close collaboration with the main customer partner Ethicon Biosurgery, part of Johnson & Johnson. Ethicon Biosurgery is also our innovation partner and plays a strong role in providing extensive knowledge about global market needs, to ensure that we always have a strong and competitive product portfolio.

All main functions in the Ferrosan Medical Devices company are in Søborg, DK including development and production facilities, so everyone sits door to door with easy access to each other.

The company is growing, and we are taking many functions to the next level including Quality Assurance to meet current and future demands. There is a long-term strategy which involves several early innovation projects as well discovering the next generation hemostatic products.

Quality Assurance representative in exciting product development projects, and cross-functional collaboration

Quality Assurance is one department with 14 skilled and dedicated colleagues counting 10 QA Senior Specialists/Specialists, a Lead Auditor and 3 Technicians. Together, we contribute all the way from product development to first receipt of raw materials to the finished products is released to the market. We are involved in daily operation as well as providing support for various product development projects ensuring compliance both internally as well as with our external partner and subcontractors.  Our environment is very welcoming and characterised by team spirit and helpfulness, also in busy times. We believe that people that support each other and have a good time together create the best results.

Your role

In the position as Senior QA Specialist for development projects, you will become QA’s representative in one of our strategically important product development projects and work closely with the project team consisting of specialists from R&D, Clinical Insights, RA and Technology Innovation to develop the next generation of hemostatic products. Your primary tasks cover:

  • Design Control – including design planning, design inputs, design output, design reviews, design verification, design validation and design transfer
  • Risk management and risk assessment
  • Usability
  • Sterilization validation
  • Qualification and validation documentation – including test methods
  • Transport studies and stability studies

You will support the project team as quality expert, set the direction and standards for compliance and quality and have an important role ensuring that Ferrosan Medical Devices continuously develop and deliver world-class products used to stop bleeding during surgery.

Ideal candidate profile

You have gathered board QA experience from being QA representative in product development projects from your previous roles. You are looking to join a dynamic company on an exciting journey where you will make difference with your expertise. You like taking responsibility and you are ready to take decisions. Equally important is your pragmatic and collaborative approach taking necessary and fast decisions – we can only succeed as a team across functions and departments. You seek the best solutions without compromising quality and you are used to handling multiple stakeholders and can land a solution with people that do not have your expertise. You are structured, have a good overview and ability to deep dive into detail when necessary

The role requires:

  • Work experience from a similar role within the medical device, pharma or medico industry
  • A master’s degree within pharmacy, biology, engineering, chemistry or similar
  • Experience with ISO 13485 and 21 CFR Part 820 as well as knowledge of the requirements for being in compliance during product development
  • Experience with design control and risk management
  • Experience with validation and qualification
  • Fluency in Danish and English, written and spoken

How to come into consideration

To apply for this position please contact Peoplement Executive Search Partner Anne Borgen, either by mail: anne@peoplement.dk or phone +45 61690101 for more information. Application should be submitted by 19 April 2022; however, we will be evaluating candidates continuously.

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