Quality Director

-Requisition Number EMEA08247 Employment Type Full-time Location Montpellier **MISSION AND TASKS**: - Implements the necessary actions to ensure the compliance of the company's activities with ISO 13485, CFR 21Part 820, Sors 98282, Directive 93/42/EEC (as amended by Directive 2007/47/EC), as well as with any reference system selected as necessary for the development of the Zimmer Biomet Montpellier site - Sets up, animates and evolves the Quality Management System according to the Quality policy established by the Corporate - Develops the "Quality Spirit" within the company - Conducts the company's certification activities according to the selected standards. - Manages all Quality documents - Carries out the systematic analysis of Non-conformities and selected customer complaint investigations in terms of risk and material vigilance and ensures communication with the impacted organizations - Supervises the controls carried out on the components and products and draws up the certificates of conformity of the final products - Defines the appropriate procedures and measures for each process to meet customer expectations by adhering to quality standards - Defines performance objectives for the Quality function. Has the authority and responsibility to ensure quality objectives and their achievement. Prioritizes QA function objectives to meet deadlines -Responsible for QA budgets. Ensures that QA actions are aligned with the company's overall strategy, enabling continuous quality improvement -As part of the management team, develops the operating objectives of the QA -Assesses quality related issues: is technically competent to evaluate design validation/product validation activities and data to ensure that design control/validation activities and data are properly implemented and used to support desired objections and conclusions. **RESPONSIBILITIES**: - Responsible for the implementation of changes to procedures, processes, design - Responsible for ensuring compliance with the regulations within the meaning of Regulation 2017/745. - Responsible for ensuring compliance with the regulations, he does not suffer any disadvantage within the organization in relation to the proper performance of his tasks - Ensures the delegation of the Management during the audits - Responsible for putting products or processes on hold - Responsible for the implementation of corrective and preventive actions, the handling of complaints, the treatment of non-compliant products - Manages the quality team- The Associate Director of Quality is attached to the EMEA Quality and Compliance organization The Associate Director of Quality is responsible for maintaining and effective the company's quality management system. He is also responsible for the regulatory compliance of the system and products with all standards applicable to electromechanical medical devices. He is responsible for reporting to top management the effectiveness of the quality system as well as the opportunities for improvement. The quality manager has the authority to initiate risk control actions such as blocking products or initiating batch recalls. It is responsible for communications with notified bodies or competent authorities. **COMPETENCIES AND REQUIRED PROFILE**: - Good knowledge of standards related to medical devices (ISO 13485, 21 CFR part 820 etc...) - A high school university degree in medicine, pharmacy or engineering related to medical or any other field with a strong quality and regulatory constraint - Good knowledge of standards related to electromechanical medical devices (IEC 60601, 62366...) as well as risk management according to ISP 14971 - Competence in time management and organization - Mastery of computer tools (Microsoft Access, Powerpoint, Excel) - Effective in oral and written presentations - Fluency in English and French - Ability to develop and maintain an organizational culture that fosters behaviors that lead to superior business performance and optimized regulatory compliance. - Act in a balanced and ethical manner in the grey areas of regulation. - Demonstrated ability to learn key products and processes quickly. - Analytical skills - Quality management and related methodology - Customer Management - Motivation and commitment to results **LOCATION**: - The position is attached to Zimmer Biomet Robotics site located in Montpellier, but is directly reporting to the hiring manager based in the USA.