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Quality Director, Medical Devise – Asnières-sur-Seine

Quality Director, Medical Devise – Asnières-sur-Seine

Quality Director – Medical Devise

 

Mission

The Quality Director defines the policy and quality objectives of the company.

S/he develops and implements quality approaches by ensuring consistency between different structures and / or directions.

Main activities 

  • Definition and proposal to the general management of a quality policy
  • Establishment, development and periodic evaluation of the quality system
  • Promoting the quality approach internally and externally and controlling its application
  • Professional relations with the administrative authorities and answers to questions on quality audits
  • Planning and control of the implementation of internal and external quality audits and surveys (customer satisfaction, process analysis …)
  • Control and validation of quality assurance plans
  • Regulatory and organizational watch
  • Monitoring of the inspections of the supervisory authorities, ANSM, EUREF, IRSN, etc.
  • Control of the implementation of quality, preventive or corrective actions
  • Management of the human resources of his organization (recruitment, evaluation, training …)
  • Definition of guidelines for training in quality management (methods, tools …)
  • Evaluate, develop and recognize the employees of his organization
  • Supervision of the QRA manager in ensuring the accomplishment of his operational missions

Location

Asnières-sur-Seine

 

CANDIDATE PROFILE

Education

Minimum of Master’s degree or equivalent (Master II) in Engineering or Pharma major or a related field to the quality assurance activity of medical equipment.

Additional training or certificate in the Quality Control/Assurance is appreciated

Languages

  • Fluent in French and English

Experiences and Competencies

  • Anticipate and estimate quality needs and identify problems in the future
  • Discuss on the quality policy and possibly to convince the general management
  • Propose and negotiate quality solutions with the various interlocutors
  • Develop and maintain professional relations with administrative and supervisory authorities
  • Evaluate the effectiveness of preventive and corrective quality actions with regard to the means
  • Communicate on quality policy internally and externally
  • Design and lead quality projects and / or programs
  • Manage a crisis situation in the event of a serious problem in relation to a product in clinical or commercial development
  • Define priorities for action and allocation of resources / resources / deadlines
  • Define quality methods and tools
  • Communicate, read and write technical documents, reports, notes – in English

Personal Qualities

  • Honest and rigorous
  • Well structured
  • Endurance to the stressful situation – diplomatic communicator
  • A positive attitude
  • Good organisational and time-management skills
  • Outstanding negotiation skills and persuasiveness

Trustworthiness and discretion when handling confidential information

 

To apply, thank you to send your application (CV + Letter) under ref. GRM – DQ to:
naoko.asada@groupe-gr.com

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