Quality Manager (m/f/n)

Bruker Corporation (Bandol 83, France) Publié il y a 29 jours

Quality Manager ISO 13485, 21CFR 820, IVDD, IVDR

  • Define and implement the company's quality policy by associating indicators and control processes.
  • Be responsible for the compliance of the company's quality management system, its products and services with internal or external quality and regulatory requirements, and ensure the maintenance of all applicable certifications (Incl. ISO 13485 and CE).
  • Further develop and permanently improve the quality management system.
  • Coordinate the pilotage and performance monitoring activities of the company's quality procedures and methodologies.
  • Contribute to instill a quality spirit among all the company's personnel.
  • To report to Bandol site management and BDAL quality management.
  • Participate in and contribute to the BDAL quality and RA team; and drive harmonization of processes within BDAL.
  • Organize and maintain the quality management system and supervise its implementation at all levels of the company.
  • Develop projects with a view to obtaining specific certifications and ensure the sustainability of the certifications obtained (ISO 13485).
  • Ensure the proper understanding and application of quality procedures and approaches through internal training and methodological assistance.
  • Identify and analyse quality problems and propose and drive corrective and preventive actions and the verification of their effectiveness.
  • Promote performance improvement plans and the culture of continuous improvement to all employees.
  • Define and monitor quality management tools.
  • Establish and maintain the quality management system.
  • Preparing and leading quality meetings and management reviews and reporting on the operation of the quality management system to management.
  • Carry out internal audits according to the established planning.
  • Drive implementation of the supplier quality management.
  • To ensure the relationship with customers on quality issues, to take care of their complaints and follow them up in order to maintain their satisfaction.
  • Carry out a risk analysis using standard norms and methods.
  • Manage the product release process: control throughout the production chain, the conformity of products to standards and referentials.
  • Manage relations with institutions, competent authorities, certifying bodies: ensure audits (planned and unannounced) and manage the reports of reactovigilance.
  • Manage relations with customers and suppliers.
  • Monitor normative and regulatory developments and assess their impact.

  • 3-5 years of experience in the field (ISO 13485, IVDD), preferably as quality management representative
  • D. or Pharmacist
  • Lead auditor
  • Fluent in French and English (verbal and written)

Helpful (but not mandatory) qualifications:

  • Experience with 21 CFR 820
  • IVDR Training

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Quality Manager (m/f/n)

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