Senior Quality Assurance Engineer

Il y a 2 mois


Paris, Île-de-France Michael Page Temps plein
Job Title: Senior Quality Assurance Engineer - Medical Device

Job Overview:

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team in the medical device sector. This role is pivotal in ensuring the highest standards of quality and compliance within our products.

Key Responsibilities:
  • Collaborate with Research & Development, Manufacturing Engineers, and production teams to ensure quality standards are met.
  • Design and implement enhancements to processes and systems aimed at improving safety, quality, and regulatory compliance.
  • Assist in managing change control processes effectively.
  • Support the qualification and approval of components.
  • Review and validate test protocols and reports associated with process validation.
  • Oversee process deviations and manage non-conformities.
  • Address internal and supplier reports regarding non-conforming materials.
  • Lead or actively participate in corrective and preventive action initiatives (CAPA).
Candidate Profile:
  • A Master's degree in engineering or a related field is required.
  • A minimum of 10 years of experience in the medical device industry is essential.
  • Proficient understanding of inspection and testing standards.
  • Familiarity with risk management principles and ISO 14971.
  • Experience with quality management systems in accordance with ISO 13485.
  • Strong statistical analysis capabilities.
About the Company:

Michael Page Santé is a leading recruitment firm specializing in the pharmaceutical, biomedical, biotechnology, and healthcare industries. We focus on connecting experienced professionals with opportunities in Pharmacy, production, R&D, commercial and marketing roles, as well as healthcare management.



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