Quality Manager (contract) - Paris

Quality Manager (contract) - Paris

Job Title: Quality Manager (contract) - Paris
Contract Type: Contract
Location: Paris, Île-de-France
Salary: Negotiable
Start Date: ASAP
Reference: QAMGRParis_1502293450
Contact Name: Nathan Wilson
Contact Email:
Job Published: August 09, 2017 16:44

Job Description

Job Summary

Responsible for site-specific aspects of the Quality Management System to ensure the company meets and maintains all applicable quality and regulatory compliance requirements.

Main duties and responsibilities

  • Manage the requirements for quality and regulatory compliance for the manufacture, sale and global distribution of diagnostic products.
  • Support for regulatory and customer audits.
  • Managing the company's key supplier base from a quality perspective.
  • Support and develop data for input into the site management reviews.
  • Provide quality and regulatory support to development and OEM projects, including the generation review and approval of process validation documentation.
  • Review and approval of technical, regulatory and QMS documentation.
  • Assist in regulatory submissions for existing and new products.
  • Support compliance of the company's Risk Files in accordance with ISO 14971.
  • Assist where required in process and product compliance to assure GMP is maintained for IVD manufacture.
  • Maintain the site complaint investigation and vigilance reporting processes, and co-ordinate site PMS activities.
  • Site responsibility for the Q-Pulse system.
  • Ensure Executive Team (through the HQARC) are advised on any quality or regulatory changes that will impact the Paris business.

Qualifications and experience required

  • Must be fluent in both verbal and written English and French.
  • Should be fully conversant with key regulations for In-vitro Diagnostic Devices.
  • Experienced and conversant with current requirements for ISO 9001, ISO 13485 (including CMDCAS), 21 CFR Part 820.
  • Qualified internal auditor to ISO 13485.
  • Experience managing suppliers from a quality perspective.
  • Previous experience in conducting process validation studies.
  • Experience in the testing and validation of software would be a distinct advantage.
  • Job Type: Contract

Required experience

  • ISO 9001, ISO 13485 21CFR Part 820: 1 year
  • In-vitro Diagnostic Devices: 1 year

Required language

Fluent French

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