Quality Systems Manager (m/f) - BE or LUX
BE or LUX, - full-time - 20.01.2022

Flen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.

At Flen Health, we are convinced that we do help people live the life they love through developing innovative technologies and bringing these to patients across the globe. We focus on patients with topical inflammatory and infectious diseases.

At Flen Health, we expect you to show grit, to take ownership of your initiatives, to go for it and we guarantee that you will then appreciate the result of your work, whether individually, as a team or company-wide as Flen Health. As an intrapreneur, you will enjoy working in a multicultural diverse environment where trust and open communication are key, and where a positive can-do attitude drives sustainable growth. We offer a flexible working eco-system, enthusiastic colleagues, and an attractive remuneration package.

We are looking for a Quality Systems Manager for an immediate start. This is a permanent full-time position based in our office in Luxembourg or in Belgium, reporting directly to the head of Quality. As Quality Systems Manager you will manage and lead the e-QMS implementation and monitor performance of the Quality Systems processes in order to comply with ISO 13485:2016, 21 CFR 820 and applicable regulatory requirements to maintain the necessary quality certification. As a highly analytical and meticulous professional, you will set up quality improvement programs to increase overall quality performance. This position would suit you perfectly if you have an excellent sense of detail, a taste for innovation and the desire to make things happen in a constant quest to improve quality at all stages.

 

What we offer:

  • Excellent working conditions
  • An innovative and inspiring work environment
  • Independent project work & responsibilities within a professional team
  • Career prospect
  • Learning and development opportunities
  • Competitive remuneration according to experience  

Your responsibilities:

  • You manage and lead the eQMS implementation
  • You identify problems and provide solutions for resolution.
    You determine Quality Systems process improvements for both compliance to ISO 13485 & 21CFR820 and overall performance
  • You are the main contact for internal departments
  • You prepare and complete quality documentation and reports regarding quality, and customer requirements by collecting, analysing, and summarising information and trends including failed processes, recalls, complaints and CAPAs
  • You drive and implement Quality awareness programs throughout the company
  • You stimulate other departments to optimize processes and documents and help where possible
  • You develop and implement quality strategies including global strategies that ensure procedures and policies meet applicable standards and regulations
  • You drive and lead quality project meetings
  • You are responsible to drive Risk management, both product and business oriented
  • You stakeholder in the Change control process, both Quality related and other
  • You maintain proper communications with other departments to ensure communication and good relationships in connection with matters related to the quality management system
  • You work in close cooperation with Internal departments to ensure QMS alignment concerning submissions, design dossiers, technical files, and other regulatory and R&D documents
  • You setup and follow up of departmental objectives and budget

Your qualifications & experience:

  • You hold a degree (Bachelor/Master) in Pharmaceutical Science, in Science or equivalent based on relevant experience
  • You can demonstrate at least 5 years of successful professional experience in a Quality department and a first experience in team and project lead
  • You are fluent both written and spoken in English, other languages as Dutch, French or German are an asset
  • You hold perfect command of quality processes and procedures and your strength is your keen eye for detail
  • You have knowledge or experience in internal auditing
  • You demonstrate an analytical thinking & problem-solving capability
  • You are experienced in product manufacturing and GxP
  • You are proficient in MS Office
  • You have strong knowledge of:
    •  
    • ISO13485 and 21 CFR 820
    •  
    • Medical Device regulation
    •  
    • QMS software
  • You have an ISO/EN auditor certificate or the desire to obtain it
  • An experience of semi-solids manufacturing and/ or Quality Control is an asset

Are you interested in working with an ambitious and very dedicated team?

Please send your application, CV and motivation letter to the following email address: recruitment@flenhealth.com

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