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QM/RA Engineer IVD (m/f/n)

Bruker
Nehren

Job-Infos

Berufsfelder

  • Entwicklung
  • Qualitätsmanagement

Gewünschte Studienfächer

  • Biotechnologie
  • Chemieingenieurwesen

Abschluss

  • Bachelor
  • Master/Diplom

Einsatzorte

  • Nehren
Stellenbeschreibung

Antrags-Nr.:: 2020-9190
- limited to 3 years -

Would you like to contribute your skills to a future-oriented company that is growing rapidly and support us in making the world healthier and saving lives? Then we, Hain Lifescience GmbH, as the manufacturer and distributor of In-vitro-diagnostics, are the right company for you. Due to our outstanding technical expertise, great reputation in the market and a convincing product portfolio, we are among the most important in the industry. Support us and become part of our family

Our customers include medical laboratories worldwide. Our main competencies are molecular genetic test systems and devices for the detection of dangerous pathogens or hereditary diseases. Hain Lifescience has been part of the globally successful technology group Bruker based in the USA since October 2018.

Aufgaben/Verantwortlichkeiten

  • Further development and maintenance of our QM system according to EN ISO 13485
  • Implementing and managing a post-market surveillance process according the new IVDR EU 2017/746
  • Implementation and further development of risk management according to EN ISO 14971
  • Communication with sales partners, authorities and notified bodies in regard to regulatory topics
  • Regular trend analysis reporting on product quality and internal key performance indicators to support senior management in taking effective decision for quality improvements
  • Assistance in the worldwide approval and registration of in-vitro diagnostics (EU and non-EU)
  • Participation in the organization an implementation of internal and external audits

Qualifikationen

  • University Degrie (Life Science background) or equivalent combination of education and experience
  • Professional experience in regulatory affairs and quality management
  • Familiar with international regulations and standards pertaining to medical devices; familiarity with EN ISO 13485, EN ISO 14971 and ability to intepret and work with regulations and standards
  • Expertise in risk management processes
  • Self-starter attitude, strong organizational skills, flexibility, commitment and ability to meet deadlines
  • Goal oreintated team player with excellent communication and conflict resolution skills
  • Knowlegde of data analysis and statistical Techniques
  • Very good German and English verbal and written language skills

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