Coordinates and supervises Quality Engineers regarding complex projects in Tecate and extends to the sending sites for any transfers. Coordinates and assures inspection plans and/or testing in receipt and/or process and finished products according to established procedures.Responsibilities:Supervises the Quality Engineering team.Uses judgment and criteria to solve problems related to his/her work area, performing highly skilled tasks (such as failure analysis) through studies (process capability, correlation analysis, DOE, etc.) and/or measurement equipment.Assures the application of the Non-conformance control system (identification, segregation, and disposal).Generates, analyzes, and presents inspection and testing reports.Notifies and requires corrective actions from the corresponding functions (purchasing, engineering, manufacturing, etc.) on non-conformances and verifies the effectiveness of corrective actions.Leads continuous improvement projects and/or multifunctional teams.Reviews the Quality Requirements for the introduction and transfer of new products and/or processes.Analyzes customer complaints and coordinates with other departments for the implementation of corrective actions.Can train other supervisors, engineers, technicians, and/or personnel from other areas, requiring advanced technical knowledge of the final product, processes, equipment, and raw materials.Addresses problems in process related to suppliers, coordinating with the receiving inspection area. Requires corrective actions from suppliers.Implements the Quality system documentation. Develops, modifies, and maintains procedures within compliance.Evaluates the performance of subordinates and recommends appropriate development plans.Supports the Quality Assurance Manager in communications with regulatory bodies and can participate in and/or facilitate audits.Education:
- Bachelor's degree in engineering or equivalent.
- Desirable: Advanced English (reading and writing that allow fluid presentations and/or participation in negotiation processes).
- Desirable: Working knowledge of Excel, Word, Project, and PowerPoint.Experience:
- 3-5 years of experience in the medical device industry.
- 5 years of experience in the Quality department.
- Desirable: Knowledge in ISO 13485, QSR (21 CFR Part 820).#J-18808-Ljbffr