Senior Quality Assurance Specialist
hace 2 meses
**Job Overview**:
Bd is seeking a skilled Senior Quality Assurance Specialist to lead the 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.
**Work Location**: Mexico
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