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Main Activities
* Develop and maintain effective supplier relationships through robust management processes.
* Participate in the selection, evaluation, and periodic assessment of suppliers according to established procedures.
* Process and follow up on supplier complaints and change notifications within specified timeframes.
* Organize and participate in change impact assessment meetings.
* Plan, conduct, and coordinate supplier and distributor audits.
* Collaborate with other departments to handle quality events, such as non-conformity, out-of-specification, change control, and corrective actions.
* Lead problem-solving groups and support continuous quality improvement projects.
* Foster internal communication by sharing information from various departments within the Quality Department.
* Act as a quality referent on projects, review new design specifications, and provide input on component quality and manufacturing feasibility.
* Investigate supplier material failures and develop corrective action plans when necessary.
* Establish material acceptance criteria and related activities.
Profile
* Demonstrate expertise in Quality Standards ISO 9001 & 13485.
* Have knowledge of MDR regulations.
* Hold a Certified Lead Auditor 13485 certification.
* Be familiar with quality tools (5P, 5M, 8D) and risk analysis methods.
* Show proficiency in English, with good comprehension and writing skills (minimum level B2).
* Have basic training in CFC or equivalent.
* Possess at least 5 years of experience in quality within the pharmaceutical and/or medical device industry.
* Exhibit autonomy, rigor, and a strong team spirit.