Quality Engineer

il y a 1 jour


Valbonne, France AMMGroup Temps plein

Key RequirementsSolid experience in Medical Devices (DM) or Electromedical ProductsStrong knowledge of ISO 13485 and IEC 60601 standardsGood understanding of Quality Management Systems (QMS)Experience in or exposure to Quality Audits (internal / external)Ability to review and validate technical documentation for complianceExperience collaborating with R&D teams on design and product qualityExcellent English level (American company all documentation and meetings in English)Strong communication coaching and leadership skillsResponsibilitiesReview and validate all project / product documentation to ensure compliance with QMS and standards (ISO 13485 / IEC 60601)Support and coach project teams to meet quality and regulatory requirementsApprove deliverables as QA representativeCollaborate with cross-functional teams to resolve quality or regulatory issuesIdentify assess and manage risks related to safety quality and complianceAnalyse non-conformities define and follow up CAPA actionsKey SkillsAPQP, Quality Assurance, Six Sigma, ISO 9001, PPAP, Minitab, Root cause Analysis, ISO 13485, Quality Systems, Quality Management, As9100, ManufacturingEmployment Type: Full TimeExperience: yearsVacancy: 1 #J-18808-Ljbffr



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