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Site Quality Leader

Indefinido
Paris
Salario: No especificado
Sin trabajo a distancia
Experiencia: > 5 años

Philips Health Technology Innovation Paris
Philips Health Technology Innovation Paris

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El puesto

Descripción del puesto

What you will do

You will lead the local quality team (1 person in the US, and 1 future QA Engineer in the Paris office) and fulfilling all obligations of the local Quality System. This role is based in Paris, but you will also provide accurate reporting on the site of responsibility to the Head of Quality from the Philips team. Ensure any/all known compliance gaps are addressed and resolved according to documented procedures and regulatory requirements expectations.

Specifically, you will:

• Act as the site Management Representative

• Host external audits

• Manage KPI performance

• Ensure CAPA/NC timeliness requirements are met

• Ensure Training curricula are accurate and appropriate for the employees within the site

• Provide guidance on quality matters pertaining to the site

• Ensure product issues are addressed immediately

• Ensure the internal audit program is executed appropriately and on schedule

• Interact with regulatory bodies, ensuring required communications are maintained

• Responsible for maintaining and remaining within the operational budget

• Ensuring employees are managed appropriately (team of 1-2 people)

Who you are

• Bachelor’s Degree plus 10-15 years’ experience in varying roles within Quality in the Medical Device field.

• Working knowledge of FDA 21 CFR 820 and Part 11, ISO 13485:2016, ISO 14971, EU MDR regulations, IEC 62304, and in-depth understanding of the MDSAP audit methodology.

• Capability to lead and influence others in a global, matrix-style organization.

• Effective communication and influence skills

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