Quality Assurance Manager - Brussel

Vacancy information

Publication date:April 10 2020
Employment type:Permanent
Sector:Medical Devices
Function Group:Quality/RA

Function Group: Quality/RA / QA Manager

Organization

Ovizio is an innovative company on a mission to design efficient microscopy solutions for life sciences applications. The company recently completed a substantial Series B financing to realise the next stage of growth. This tech start-up located in Brussels consists of a group of 20 ambitious professionals who are highly motivated to bring Ovizio to the next level.

Ovizio develops microscopes and non-invasive tools that are easy-to-use. These applications have the ability to produce three-dimensional, real-time images of living cells without labels. This technology can benefit a range of applications, from R&D to manufacturing processes, and enable significant cost reduction and quality improvement. Ovizio’s microscopes are particularly convenient and robust for automated cell culture monitoring, analysis and quality control. The client base of Ovizio exists out of GMP regulated companies in the pharmaceutical and life sciences industry.

Function

You will have the opportunity to be fully end-responsible for all Quality and Validation related aspects. You will define the short- and long-term courses, and liaise and manage the two key contract manufacturing partner. Therefore, you will be instrumental to the success of the company. In this position, you will report directly to the CEO and will be fully responsible for the Quality Assurance within Ovizio.

As the basic foundation of the quality system has been implemented, it will be your task to further develop and implement the quality system according to ISO:9001 guidelines. This includes setting up new procedures and updating existing ones, including their related IT workflows. As you will keep Ovizio compliant with respect to applicable regulatory standards and guidelines, you will be the lead in audits. Throughout your tasks, you will work closely with a motivated group of product-, R&D- and software engineers to ensure the quality of the products, design processes and supply chain processes within the Ovizio.

To be able to meet quality and validation requirements from development to product launch, you will be responsible for multiple design-related tasks, such as: design control, design validation, design documentation approval, overall support in product design by using your knowledge on materials and manufacturing processes, developing testing plans, production qualification and supporting in risk management. As you will be the technical expert on quality within Ovizio, you give design control training and communicate development regulations towards both co-development partners and third-party suppliers. This ensures that Ovizio products get certified and stay certified. Throughout this expertise, you provide vision and leadership for the strategic projects with Ovizio’s key accounts.

As you help Ovizio become an organisation which is focused on continuous improvement and supply quality excellence, you will be responsible for the supervision of Ovizio’s two main suppliers for their instruments and disposable systems. This includes building an operational plan which is focused on continuous improvement and supplier quality excellence, and the building and managing of internal and external relationships.

Requirements

To be successful in this position, you bring the following experience:

  • At least 5 years of quality assurance experience, including design assurance
  • Strong track record with ISO:9001 and cGMP
  • Experience working with high end measurement products, such as bioprocessing machinery, life science instrumentation or diagnostic solutions
  • Experience with software-based solutions
  • Previous experience with supply chain excellence and continuous improvement projects
  • Master’s degree in a technical field
  • Strongly skilled in English, preferably also in French or Dutch


Personality wise, you recognise yourself in the following profile:

  • Strong influencing and management skills while simultaneously demonstrating the attributes of collaboration, team building and participative decision making
  • Being successful in a start-up environment: learning quickly and being flexible
  • Being an effective coach and trainer for people less familiar with quality systems
  • Ability to communicate effectively towards all levels of the organisation
  • Excellent analytical skills and the ability to present the findings in a polished and concise manner

Offer

This role offers you to:

  • Become end-responsible for the quality activities within a promising start-up
  • Work on strategic projects and maintain key-accounts
  • Contribute to cutting-edge technology for tomorrow’s markets
  • Work in a very energetic but almost family orientated environment where everyone has a clear passion for science and technology

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Consultant Quality & Clinical | Medical Devices

+31(0)6-13143973
+31(0)23-7548660
s.cepella@qtcrecruitment.com

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