Responsibility: Supervise and direct all Inspection personnel to ensure that the Incoming Inspection, Process Inspection, Line Inspection and Final Inspection meet the requirements established by our clients. Ensure that Quality personnel work in accordance with the requirements, Policies and Training established by the company. Review and approve process qualification protocols and reports. Track and analyze key performance indicators Review and Implement Quality Formats. Maintain quality records on file. Hire and Train Quality Personnel. Maintain communication related to Quality, with the customer and the Suppliers. Follow up on Corrective Actions. Maintain all instruments in a compliant Calibration state. Follow up on all Non-Conformities found in Quality Area Audits. Be at the forefront of Implementation and/or changes with respect to ISO 13485 & ISO 9001 and report to the General Manager. Promote and seek methods for the constant improvement of the process. Analyze quality statistics and suggest methods for the constant improvement of the Company's quality. Carry out the verification of control and test instrumentation. When you have been accredited as an internal auditor, you must schedule and distribute your regular activities to perform on time all the activities required in the applicable procedures for the execution of internal audits according to the current program. When requested, you should schedule and distribute your regular activities to attend in a timely manner and actively participate in all Corrective Action Quality Circles Preventive Actions and Continuous Improvement that our System requires. Responsible for holding departmental meetings at least 2 times a year. Responsible for ensuring that the computer equipment in his/her work area has direct access to the electronic Menu of Consultation Documents of the Quality System. Responsible for determining and establishing in writing the objectives of the department. Qualifications: Knowledge of FDA Medical Device Regulations, cGMP, ISO 13485, COFEPRIS, UL, and ISO 9001. Knowledge and application of the Quality Manual and the procedures of the Quality System. English & Spanish language proficiency Metrology Command of PCs and programs such as Excel and Word Skills: Use of basic measurement tools. Conducting quality circles or methods of analysis and problem solving. Clear and direct communication and dealing with staff at all levels. Reading and interpreting plans or drawings. Education: Bachelor's degree or Engineering Experience: Knowledge of manufacturing processes. (3 years minimum) Use and application of ISO 13485 and ISO 9001.
