Distribution Quality Assurance Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil ConvaTec Tempo inteiro
Job Title: Distribution Quality Assurance Specialist

ConvaTec is a global medical products and technologies company, focused on solutions for the management of chronic conditions. We are seeking a highly skilled Distribution Quality Assurance Specialist to join our team.

Key Responsibilities:
  • Support the ConvaTec Distribution Quality group in ensuring an effective Quality System is in place at ConvaTec with respect to Third Party Logistic Service providers and Distribution Centers.
  • Manage supplier assessments to determine the state of Quality Systems and process capabilities at distribution suppliers in support of ongoing business and new product introductions, end-to-end.
  • Use auditing as an initial evaluation or proactive tool for improvement, where appropriate.
  • Ensure supplier systems are aligned with current regulatory requirements, standards and ConvaTec policies and requirements.
  • Responsibility for providing oversight of supplier assessments, escalating issues and leading risk assessments and mitigations as appropriate.
  • Collaborate with key business partners to drive supplier nonconformance investigations and define effective corrective actions.
  • Develop consistent written standards globally on distribution activities that includes but not limited to: Relabel, Temp Control & Quality agreements.
  • Generate and monitor appropriate key performance indicators to assess distribution supplier performance in a timely manner to drive resolution of corrective actions from the suppliers.
  • Focus on establishing, maintaining and improving distribution supplier performance metrics, policies, and procedures in administering quality relationships with the external parties globally.
  • Collate and share information/data through reports and follows up on identified improvement opportunities.
  • Involve in the development and execution of the annual Supplier Audit schedule.
Requirements:
  • Previous experience in the medical device industry and in Supplier Quality Control.
  • Experience in internal and supplier related CAPA/NC.
  • Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis.
  • 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.
  • Ability to make decisions guided by established policies and procedures.
  • Develop and implement solutions to a wide range of product or business needs.
  • Knowledge of quality control principles and their relationship to relevant regulatory requirements.
  • Knowledge of regulatory requirements that affect the medical device manufacturing business and put policies and systems in place to achieve conformance: QSR Part 820, ISO 13485, MDD 93/42, ISO 9001, GMP Parts 201 and 211, EU MDR.
Qualifications/Education:
  • BS in Science or Engineering.
  • Fluent English.
  • Quality Auditor or Lead Auditor certification is preferred.
  • This position will be required to travel (25%) to ConvaTec and supplier locations.

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