Job Description Summary
Provides technical support to the process, product quality and effectiveness in the search for continuous improvement of the material, product or quality and reliability of the process.
Actively participates in the implementation, validation and integration of new products, technologies, and processes in the quality system.
This work must be performed in compliance with current regulations, standards, and policies applicable to the organization.
Job Description
General Duties and Responsibilities
1.Develops quality measurement and control for the material, process and product with the objective of providing adequate control at a minimum cost and analyzes the data obtained in search of trends and opportunities for improvement.
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2. Coordinates Quality Notifications (QN), Corrective Actions (CAPA) and Customer Complaints (CIR) as assigned.
3. Supports regulatory compliance by developing procedures and processes with strict adherence to the quality system and can participate in internal audits either as an auditor, or in internal and external audits, supporting the audit process or as an auditee.
4. Lead quality improvement projects or participate in supporting projects where the participation of the Quality area is required.
5. Generate reports on the status of your areas of responsibility and escalate critical or risk situations.
Specific Roles and Responsibilities
1.Determines quality objectives and goals, which must be defined in specifications, drawings and test procedures.
2.Analyzes product and process proposals that are in compliance with the company and regulations for the manufacturing of Medical and/or electrical/electrical products.
3.Analyzes quality information and recommends adjustments to product design, manufacturing process, equipment, and quality systems.
4.Participates in the review and disposal of non-conforming material in the "MRB" review board and engineering change orders and follows up on corrective actions.
5.Investigate and implement process control, inspection and testing strategies at strategic production points and assembly areas.
6.Conduct process capacity studies on production lines and equipment.
7.Evaluate product claims. Provides/proposes the solution and responds to the complaint.
8.Supports internal and external audits.
9.Has authority to review and approve documents controlled by the change control system.
10.Provides training on product and process as appropriate.
11.Performs verifications and validations of test equipment, processes and building facilities.
12.Escalates critical or risk situations to Management.
13.Updates and improves testing procedures.
14.Provides support in accordance with its functions to the transfer of products or modifications to parts, materials and processes, as well as the implementation of new products.
15.Supervises test method qualification and capability studies (R&R).
Required Skills
Optional Skills
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Primary Work Location
MEX Tijuana - Parque Sur
Additional Locations
Work Shift