Quality Assurance Assistant Manager

About the Role

As a Quality Assurance Assistant Manager, you will play a pivotal role in ensuring the quality compliance and system effectiveness of our medical device manufacturing. You will lead QA operations, manage audits, oversee regulatory compliance, and coordinate product release activities, working closely with global and local stakeholders.

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Key Responsibilities:

• Management of the Change Control Process: Oversee and ensure effective implementation of change control procedures.
• Management of the NC and CAPA Process: Handle non-conformances (NC) and corrective and preventive actions (CAPA) from raw materials to finished products.
• QA Supplier Management: Manage all aspects of quality assurance for suppliers to ensure compliance with standards.
• Document System Management: Oversee the management and maintenance of the document control system.
• Regulatory Affairs Management: Handle local regulatory affairs matters to ensure compliance with relevant regulations.
• Audit Management: Manage internal and external audits to ensure compliance with quality standards.
• Team Leadership: Lead a team of 7 engineers and officers to ensure the effectiveness and efficiency of our quality assurance activities.

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Qualifications

• Experience:

  • Strong leadership and team management skills.
  • Excellent communication and organizational skills.
  • In-depth knowledge of quality assurance processes and regulatory requirements in the medical device industry.

• Skills:

  • Fluent in English (spoken and written).
  • Proficient in MS Office (Excel, Word, PowerPoint).
  • Leadership and communication skills to manage QA team and external interfaces.

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Why Join Us?

• Be part of a global French medical device leader.
• Work in a fast-growing, international-quality certified environment.
• Collaborate across borders with high standards of professionalism and care.