Quality Engineer

hace 3 días

Del Norte, México Convatec A tiempo completo

**About Convatec**

**About the role**:
Participate in changes within the project portfolio in Convatec 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**
- Contribute to the development and execution of validation protocols (e.g. IQ/OQ/PQ) for new and existing
products and processes.
- Support test method validation for in process checks and NPD development method to ensure critical-toquality (CTQ) attributes are defined and controlled.
- Supporting business unit in assuring compliance with internal and external requirements according to
standards, customers and authorities.
- Support external and internal audits as applicable.
- Support, participate and perform statistical analysis, sampling plans, quality control plans and capability
studies to support product development and manufacturing.
- Act as a support for process FMEAs and validation strategies, ensuring robust design and smooth transfer to
manufacturing.
- Work closely with key stakeholders like R&D, Manufacturing, Regulatory, and Supply Chain teams to ensure
quality is embedded in all phases of product development and lifecycle management.
- Support, participate, lead cross-functional teams in implementing process improvements and resolving quality
issues.
process development

**Requirements**:

- Bachelor’s degree in engineering or related careers.
- Minimum 2+ years in a similar role, preferably within the medical device industry but not essential.
- Regulatory and compliance knowledge of validation.
- Knowledge and experience of working with a Quality Management System within Medical Device manufacturing.
- English proficiency: Intermediate - Advanced.
- Microsoft Office proficiency: Intermediate - Advanced.

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**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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