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Product Quality Engineer
hace 2 semanas
**About Convatec**
**About the role**
Participate in changes within the project portfolio in SEG MX ensuring compliance with internal and external requirements according to standards, customer, and authorities; ensuring quality system is developed, maintained, and improved; assuring Process Validation and CCR system is followed accordingly and supporting 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 to ensure adequate communication/information between departments and sites to secure a complete DMR before qualification starts.
- Assist project team regarding external tests and verifications, including biocompatibility and stability testing, when required.
**Requirements**:
- Bachelor’s degree in engineering or related careers.
- 2 years of experience in manufacturing industries, working with project/processes implementations and new products introduction.
- Knowledge of Quality Control Systems.
- Experience working in process lines.
- English proficiency: Intermediate - Advanced.
- Microsoft Office proficiency: Intermediate - Advanced.
- Desirable knowledge on Trackwise, Lotus or related softwares.
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