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Quality Manager - Medical Technology

Date: Oct 12, 2021

Location: London, DE

Company: Dover Corporation

Quantex is headquartered in London, England, and has developed a fundamentally new innovative single-use positive displacement pump technology. Its products solve the challenge of enabling precision and micro dosing over a wide range of pressures, temperatures, viscosities and flow rates in hygienic and sterile applications where disposable pumps offer a superior value-proposition.  The fixed displacement rotary action ensures the dosing accuracy without the need for periodic calibration.  Single use application requires no cleaning or maintenance, and reduces contamination risks, cleaning costs and maintenance downtime and expense.

The Quality Manager – Medical Technology will be responsible for managing the quality management system and ensuring that products adhere to quality standards, while assessing current processes and procedures for improvement.

 

Essential Duties and Responsibilities

  • Management and further development of the quality management system according to ISO 13485
  • Analysis, assessment and monitoring of existing processes
  • Creation of process descriptions, standard operating procedures, work instructions and other relative documents
  • Connection of the QM system in London to the QM system at our site in Finning, Germany
  • Planning and implementation of internal training courses and internal audits
  • Derivation and implementation of measures based on the regulatory and statutory requirements, ensuring compliance with all applicable requirements
  • Coordination of supplier management, creation of quality assurance agreements
  • Processing of change management and complaint handling procedures for our medical and non-medical products, further development of these systems
  • Issuance of RoHS and REACH statements
  • Handling of reportable incidents
  • Post-market surveillance of products

 

Required Job Qualifications

  • Knowledge of quality management systems and regulatory requirements for medical products
  • Completed studies in engineering, medical technology or science, or technical training
  • Good command of written and spoken English
  • Willingness to travel between company locations

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other factors prohibited by law.


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