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Product Quality Engineer

hace 4 meses

Reynosa Tamaulipas MexicoParque Industrial Del Norte, México Convatec A tiempo completo
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. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit

About the role

Participate in changes within the project portfolio in Sustaining Eng. Group, and hereby achieve:

  • Compliance with internal and external requirements according to standards, customer, and authorities
  • Ensure quality system is developed, maintained, and improved.
  • Assure Process Validation and Change Control Request system is followed accordingly.
  • Support as leader on quality issues or non-conformities raised from the project-change.

Key responsibilities

  • Update and develop quality procedures, quality specifications as required in the project-change.
  • Draw up and/or follow up on internal deviations, rationales, statements, and preventive actions. Supporting the quality system in the adequate handling, for instance, non-conformities activities, CAPA activities.
  • Responsible for Updating Risk Management Plan, including Use/Design FMECA and Process FMECA within a new project/change.
  • Responsible for identifying all affected documents on a change/project (DMR).
  • Participate in design review and design examination.
  • Review protocols and reports (documentation) regarding verification/validation processes, in applicable phases.
  • Obligated to prevent the occurrence of risk ad of adverse impact on product quality, function, performance, usability, safety, and its intended use.
  • Responsible for Sterilization Evaluation Report.
  • Act as advance impact assessor in a CCR.

Requirements

  • Bachelor's degree in engineering or similar technical education (required)
  • Min 3 years on expiring working in similar position (preferred)
  • Experience from Medical Device Industry or other regulated industry (preferred)
  • Experience with cross organizational projects (preferred)
  • Knowledge of process validation (required)
  • Fluent in oral and written English (required)
  • Experience on measurement techniques, root cause investigation and statistics (required)

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