Distribution Quality Assurance Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil ConvaTec Tempo inteiro
About the Role

We are seeking a highly skilled Distribution Quality Assurance Specialist to join our team at ConvaTec. As a key member of our Distribution Quality group, you will play a critical role in ensuring that our quality systems are effective and compliant with regulatory requirements.

Key Responsibilities
  • Supplier Quality Management: Manage supplier assessments to determine the state of quality systems and process capabilities at distribution suppliers.
  • Auditing and Quality Improvement: Use auditing as an initial evaluation or proactive tool for improvement, where appropriate.
  • Regulatory Compliance: Ensure supplier systems are aligned with current regulatory requirements, standards, and ConvaTec policies and requirements.
  • Risk Management: Provide oversight of supplier assessments, escalate issues, and lead risk assessments and mitigations as appropriate.
  • Collaboration and Communication: Collaborate with key business partners to drive supplier nonconformance investigations and define effective corrective actions.
  • Process Development: Develop consistent written standards globally on distribution activities, including but not limited to: relabeling, temperature control, and quality agreements.
  • Performance Metrics: Generate and monitor appropriate key performance indicators to assess distribution supplier performance in a timely manner to drive resolution of corrective actions from suppliers.
  • Global Quality Relationships: Focus on establishing, maintaining, and improving distribution supplier performance metrics, policies, and procedures in administering quality relationships with external parties globally.
  • Reporting and Improvement: Collate and share information/data through reports and follow up on identified improvement opportunities.
  • Annual Audit Schedule: Involve in the development and execution of the annual Supplier Audit schedule.
Requirements
  • Experience: Previous experience in the medical device industry and in supplier quality control.
  • CAPAs and NCs: Experience in internal and supplier-related CAPA/NC.
  • Risk Management: Demonstrated knowledge and experience of risk management and the application and use of risk management tools such as FMEA, process mapping, and hazard analysis.
  • Skills: Strong prioritization and coordination skills, ability to work with electronic databases (Documentum, TrackWise, SAP), advanced computer management skills including Microsoft Word, Excel, and Visio, ability to negotiate and partner with internal and external customers to enhance operational effectiveness.
  • Education: BS in Science or Engineering, fluent English, quality auditor or lead auditor certification is preferred.

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