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Senior Quality Assurance Manager

Il y a 2 mois


Montmorency, Île-de-France Michael Page Temps plein
About the Role



As a Senior Quality Assurance Manager, you will be responsible for:

  • Developing procedures, work instructions, and key performance indicators.
  • Leading and developing a team of Quality Engineers, setting their objectives and regularly monitoring their performance.
  • Monitoring and addressing any unfavorable trends in key performance indicators.
  • Collaborating closely with the operational function to improve the local quality management system.
  • Ensuring that site validations are implemented on time.
  • Providing close surveillance and follow-up of any NCE/CAPA raised against the assigned process at the site.
  • Supporting the Site Quality Assurance Director in process audits, preparing and ensuring follow-up of internal and external audits.
Requirements

To be successful as a Senior Quality Assurance Manager, you will need:

  • A degree in quality or engineering.
  • Experience with medical device manufacturers.
  • Strong organizational skills.
  • A proven ability to successfully lead people and projects.
  • Fluency in English.
  • Knowledge of the 93/42/CEE directive on medical devices, ISO 13485, and ISO 14971.
  • Experience as an Internal Auditor or Principal would be an asset.
About Michael Page

Michael Page Healthcare works with the pharmaceutical, biomed, biotech, and healthcare industries, supporting their senior recruitment needs in areas such as pharmacy, production and R&D, commercial and marketing, and healthcare management.