Spec 2, Quality Assurance

hace 20 horas

Reynosa, México BD A tiempo completo

**Job Description Summary**: Responsible for providing leadership and guidance to the supplier to ensure compliance to established corporate standards and to regulated agencies for industry (ISO, FDA and others as applicable). Responsible for the planning, development and implementation of quality systems that support the organization in the successful management of suppliers.

**Key Responsibilities**:

- Review and maintenance of all Quality Agreements
- Maintain communication with Regulatory to assure accurate identification of critical and crucial suppliers.
- Coordinate the completion of Supplier Surveys/Assessments.
- Work with Procurement/Sourcing during supplier selection to provide quality-related input for potential suppliers.
- Support supplier audits and improvement projects.
- Provide support / actively participate in internal and external audits (FDA, ISO, Corporate, and Internal)
- Work with Corporate project teams to coordinate and implement supplier quality initiatives in the plant.
- Provide guidance on documentation associated with supplier qualification and supplier-driven changes including supplier validations, supplier quality agreements, process controls, and compliance to regulations and industry standards.
- Periodically assess suppliers and Supplier Quality team practices to ensure global regulatory requirements are met.

**Qualifications**:

- Bachelor’s degree in engineering or equivalent.
- 2 years of experience, medical device preferred.
- Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification
- Strong working knowledge of statistical quality tools and statistical process control (SPC)
- Strong working knowledge of QSR, ISO, MDD/MDR, Risk Management, and Canadian Medical Device requirements preferred.
- Demonstrate effective communication, presentation and influencing skills, bilingual English and Spanish.

**Primary Work Location**: MEX Reynosa

**Additional Locations**:
**Work Shift**:

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