Head of Quality Management Medical Technology (m/f/o)

Your tasks

  • Overall responsibility for the quality management system (QMS) in accordance with ISO 13485 and 21CFR Part 820
  • Function as quality management representative (QMB) vis-à-vis authorities, notified bodies, and customers
  • Management and further development of the QM team and subordinate teams (quality assurance, testing, regulatory affairs, and process optimization)
  • Planning, conducting, and following up on internal and external audits
  • Monitoring compliance with legal and regulatory requirements (MDR, FDA, etc.)
  • Further development and digitalization of the quality management system
  • Processing deviations, complaints, and CAPA measures
  • Conducting training and awareness measures on quality, compliance, and regulatory issues within the company
  • Close cooperation with the development and production departments

Your profile

  • Degree in medical technology, engineering, or a comparable field
  • Several years of experience in quality management in medical technology, ideally in the field of development and series production
  • Experience in managing a QM team or department
  • In-depth knowledge of ISO 13485, ISO 14971, and FDA regulations (21CFR Part 820)
  • Experience in leading a team and dealing with audits and certifications
  • Confident manner when dealing with authorities and notified bodies
  • Analytical thinking, structured approach to work and a strong sense of responsibility
  • Very good written and spoken German and English

We offer:

  • Security: A permanent employment contract in a future-proof market
  • Development opportunities: Regular training and targeted, individual employee development
  • Working atmosphere: A pleasant and friendly working environment and
  • flat hierarchies

  • Performance-related remuneration: We offer attractive, performance-based pay

    In addition:

  • Flexible working time models for work-life balance
  • Short decision-making processes
  • Informal culture among colleagues
  • Team events, summer parties, and Christmas celebrations
  • Anniversary benefits
  • Flu vaccinations
  • And, of course, the classic fruit basket
  • Written and spoken German and English skills

Convinced? Then become part of the BYTEC team

Please send your application documents (cover letter, CV, certificates, earliest start date and salary expectations) to Ms. Dipl.-Kff. Claudia Coenen:

  • By e-mail:  bewerbung@bytecmed.com 
  • By post:
    • BYTEC Medizintechnik GmbH
    • Mrs. Dipl.-Kff. Claudia Coenen
    • Hermann-Hollerith-Str. 11
    • 52249 Eschweiler
Dipl.-Kff. Claudia Coenen
Human Resources
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