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SMQ Engineer

Full-time
Paris
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Job description

In an international start up environment, he / she will be in charge of setting up, developing and maintaining the Company's quality assurance system, in accordance with its quality policy and according to the regulations in force in countries where will be marketed products. Direct report to the co-founder & CTO, your missions will be :

  • Set up the QMS by identifying the company's product processes and support processes, and mapping them
  • Ensure that the company's quality management system complies with European and international regulatory requirements, including US regulations
  • Perform and follow internal and supplier quality audits
  • Establish and suggest quality objectives and monitor their implementation using performance indicators
  • Create, implement and follow the quality plan
  • Approve quality system documents: pilot document management, general quality training
  • Participate in reviews of new product development projects
  • Participate in the change management process of products or processes
  • Report to the General Management the efficiency of the quality management system
  • Identify, evaluate and implement corrective and preventive action plans
  • Check and follow requests for exemptions
  • Participate in the processing of customer complaints
  • Accompany trades in the formalization and documentation of processes, and define their management in order to put them under control
  • Coordinate audits and inspections of authorities
  • Be a guarantee of conformity.

Profile needed

English spoken mandatory

Excellent knowledge of quality standards (ISO, FDA ...)

Good knowledge of FDA inspections

Good pedagogue and good negotiator: strong proposal for support functions

Good communicator

Good coping, communication and organizational skills

Ability to integrate into a dynamic structure in full development.

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