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Quality Engineer for Medical Devices

Il y a 2 mois


SalondeProvence, Provence-Alpes-Côte d'Azur, France Biotech Dental Temps plein
About the Role

Biotech Dental, a leading French manufacturer of medical devices and digital solutions for dentists and dental laboratories, is seeking a Quality Engineer to join its team. As a Quality Engineer, you will play a crucial role in ensuring the quality of our medical devices and meeting regulatory requirements.

The successful candidate will be responsible for implementing a customer complaint process and associated procedures. You will also be responsible for monitoring and analyzing customer complaints, identifying trends, and implementing corrective actions.

Key Responsibilities
  • Receive, evaluate, and analyze customer complaints
  • Initiate corrective action plans with operational services
  • Write responses to recurring customer complaints to ensure consistency and customer satisfaction

You will also have the opportunity to participate in:

  • Implementing and monitoring the SMQ (Management System for Quality)
  • Creating, updating, and improving Quality documents
  • Treating and analyzing non-conformities
  • Managing, tracking, and evaluating the effectiveness of ACAP (Corrective and Preventive Actions)
  • Conducting Quality training sessions: on-site training and awareness sessions
  • Managing Quality administrative files
  • Classifying and archiving documents

Excellent communication skills will be essential for investigating customer complaints and responding to customers in a timely manner. Fluency in English (oral and written) is required for this role. You will also need to be able to assess the urgency of complaints and take appropriate action to respond to customers promptly.

Requirements

To be successful in this role, you will need:

  • A Bachelor's degree in a scientific or biomedical field
  • Significant experience in quality and medical devices
  • Essential skills:
    • Knowledge of ISO 13485, Regulation 2017/745, and 21 CFR
    • English (written and oral)
    • Good writing and communication skills
    • Proficiency in Excel, Word, and PowerPoint

Join a unique company culture that embodies our mission: 'Creating a world of smiles': https://biotechdentallife.com/