Distribution Quality Assurance Specialist

2 semanas atrás

São Paulo, São Paulo, Brasil ConvaTec Tempo inteiro
Job Summary

Pioneering trusted medical solutions to improve the lives we touch: ConvaTec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. ConvaTec's revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC).

Key Responsibilities:
  • Support the ConvaTec Distribution Quality group, which is responsible for ensuring that 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.

Equal Opportunities:
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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