General Responsibilities:
Contribute with the quality objectives within maintenance management.
Meet with all those applicable requirements of the ISO 13485 & FDA, CGMP Administrate the Maintenance Management System in accordance with the quality system to contribute at production schedules are completed with Quality, Quantity and timely.
Fulfil the maintenance objectives.
Support and supervision to maintenance personnel to solve any problem with equipment, machinery and get expertise support to Denmark staff or equipment’s suppliers if is needed.
Assign resources needed on validations and re validations for equipment and different processes.
Follow up the general procedures, organizational plans, strategies and polices of ID Mexico.
Hire and keep the personnel in the department, following the policies established in the company.
Responsible to develop and sustain a training program for all maintenance personnel, make sure the follow up and record it. Keep updated all team trainings. Investigate and fix malfunctions of equipment's and systems with recurring problems.
Contribute to the spare parts inventory handling to avoid jeopardize the product delivery timely.
Follow the requirements of the approved budget.
Process control specifications are followed, and it is properly recorded.
Warn the validation team when spare parts are replaced in validated stations and verify that equipment and process has been properly validated before usage.
Communicate if anomalies are detected on the test and measured equipment’s calibrated by QC, and also if one is out of calibration.
Support to provide training in handling and safety for the equipment's for the production operators and recorded it.
Manage and supervise the daily activities within the members of the department.
Review and approve with a functional approach all Quality system documents related to the department.
Support on implementation of preventive and corrective actions as much to the safety and quality system previous to problems analysis done by the interdepartmental team.
Follow the safety rules of the company and the government.
Know, apply and comply with the company quality policy.
Education, training and competence:
Engineer degree in Mechanical, Electronic or electromechanical.
Experience in a similar position.
Written and spoken English required.
Knowledge of requirements of FDA QSR's GMP's and ISO 13485 or similar regulations, preferred.
Experience in equipment transfers.
Experience in problem solving tools.
Familiar in the used of common computer software packages.
Experience on budget administration.
Knowledge’s of CMMS software for maintenance activities management. Compliance with document 4908028.
Communication, team work and influence skills.
Project management, preferred.
Induction to ISO 14001:2015.
Induction on Environmental Legal Requirements, Training on Applicable Environmental Management System Documents, Disaster Care and Response, Applicable Operational Controls, Determination of Applicable Significant Environmental Aspects, and Impacts, EHS Policy and Environmental Objectives
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