- Location
- REY-Reynosa Infusion Devices, Mexico
- Type
- Full-time
- Department
- Operations
- Seniority
- Manager
- Experience
- 3+ years
- Closing date
- Today
- Source
- Workday
Description
General Responsibilities:
To support needed resources on validations and re validations for equipment involved with different processes.
To verify that equipment and process has been properly installed and validated before usage.
Communicate if anomalies are detected on the test and measured equipment’s calibrated by QC, and if one is out of calibration.
Process control specifications are followed, and it is properly recorded.
Give support to maintenance supervisors by solving any problem with equipment, machinery and contact Denmark o suppliers if it is necessary.
Excellent handling of inventory of spare parts to avoid jeopardize the production.
To investigate and fix malfunctions of equipment's and systems with recurring problems
To contribute our production schedules are completed with Quantity, Efficiency and on time.
Meet with all those applicable requirements of the ISO 13485 & FDA, CGMP.
Responsible to develop and sustain a training program for new personnel, make sure the follow up and record it. and keep updated all the team.
Support to provide training in handling and safety for the equipment's for the production operators.
To follow up of the general procedures, organizational plans, strategies and polices of ID Mexico.
To hire, train, and keep the personnel in the department, following the policies established in the company.
Plan and follow the requirements of the approved budget.
Supervise and manage 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 quality system (processes and clean room) as like to the safety system previous to processes problems analysis done by those departments.
To follow the safety rules of the company and the government.
Fulfill with the quality objectives.
Avoid stoppages on facilities machinery to contribute to reaching the production schedules with Quality, Quantity and on time.
To give support and supervision to facilities supervisors to fix malfunctions of facilities and installations machines equipment with continues problems.
Support on the EHS activities as well to the equipment related to plant or operations safety.
To take decisions to do urgent repairs that affect the production programs.
To take corrective actions when a process is out of specifications.
To repair, maintain and make any necessary changes to make the equipment work properly.
Report immediately any potential problem and solutions to his immediate supervisor.
To be the safety leader in handling equipment and machinery.
Stop and fix process when they are out of specifications limits and the quality can be on risk.
To report delays in delivery due problems that needs to be fixed.
Hire personnel, with the appropriate approval from the plant manager.
Operate within the approved budget and the product cost.
To participate in the setup of the annual budget used for manufacture, facilities and EHS needs.
Skills & experience:
Engineer degree in Mechanical, Electronic, or electromechanical.
3 to 5 years of experience in the position.
Written and spoken English INDIPENSABLE.
Knowledge of requirements of FDA QSR's GMP's and ISO 13485 or similar regulations, preferred.
Experience in equipment transfers.
Experience in problem solving techniques.
Familiar in the used of common computer software packages.
Experience on budget administration.
Experience on building installations and equipment.
Knowledge on the safety regulations.
Interpretation Course in the ISO 14001:2015 standard, Induction in Legal Requirements in Environmental Matters, Training in the documents of the Environmental System, Attention and Response to Disasters, Operational Controls that correspond to them, Determination of Significant Environmental Aspects and Impacts that correspond to them, EHS Policy and Environmental Objectives.
What you’ll get:
Competitive salary + bonus
Training & development
Collaborative, supportive culture
Ready to join us?
At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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About Convatec
Pioneering trusted medical solutions to improve the lives we touch:
Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs. Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.