Empleos de Greatbatch medical, s de r l de

The Calibrations Coordinator is responsible to maintain M&TE (measurement and test equipment) in compliance status.

The Calibrations Coordinator is responsible to have updated the records and the electronic database that supports calibration, verification, or both for M&TE of Centerpiece Sterilization facility.

This role, which reports directly to the Operations Manager, will support Centerpiece's growth and Centerpiece's operational excellence strategies by ensuring the proper functioning of the equipment, as well as compliance with its quality system.

Essential Responsibilities

• Maintain updated M&TE inventory reviewing with import/export, maintenance and user departments.
• Develop and review calibrations requirements for each one of the M&TE in the inventory.
• Support through close communication the process to maintain the M&TE in service within calibrated status,providing either internal or external calibration services.
• Coordinate suppliers, purchasing, finance, import-export, and maintenance to provide timely calibration servicesto process equipment.
• Write and update procedures, instructions, and forms related to calibration processes, provide training for M&TE users.
• Follow up M&TE related corrective actions derived from non-conformances in process (failures, non conformances, costumer complaints, etc.) and provide feedback for investigations.
• Responsible for keeping primary standards in calibration.
• Responsible to maintain calibrations records (written and electronical) updated.
• Responsible to coordinate and analyze results of regular and extraordinary temperature (and relative humidity) profiles to preconditioning and heated aeration cells and rooms.
• Responsible to have M&TE identified in order to determine its calibration status.
• Attend internal, customer and third-party audits also as audit observations as calibration SME.
• Provide continuous status of M&TE inventory through charts, statistics, and metrics.
• Prepare monthly report of activities.
• And other duties as requested that pertains to metrology and calibration.

Esporadic responsabilities

• Register new assets: filling out and coordinating the filling of new asset forms.
• To define calibration requirements for new assets.
• Register new assets in the electronic database establishing calibration frequency and profile schedule.
• Provide support to process department activities as requested.

Required Knowledge, Skills, and Experience:

Academic background

• Bachelor’s degree in engineering or related

Work experience

• Minimum of 5 years involved in calibration activities in a regulated industry such as medical devices, pharmaceutical or sterilization industry.
• Has professional presence with a level of comfort interacting with associates at all levels of an organization (internal and external), including executive management and customers.

Technical skills

• Experience in the creation and following of the calibration schedule.
• Experience in the creation and analysis of key metrics, and trend analysis.

Soft skills

• Commitment to product quality, Centerpiece quality system and applicable regulations (federals, local and state).
• Ability to successfully manage multiple projects simultaneously.
• Fosters and actively contributes to a positive team working environment.
• Is a highly motivated, self-starting person with initiative to improve processes.
• Excellent interpersonal skills and a collaborative management style.
• A demonstrated commitment to high professional ethical standards and a diverse workplace.
• Committed to safety.
• Work is highly dynamic, and employees may be expose to stress due to work demands.
• Teamwork is essential.

Languages

• Intermediate to advanced English, both written and spoken.

Sueldo: $1,200.00 - $1,800.00 al día

Beneficios:

• Descuento de empleados
• Descuento de gimnasio
• Estacionamiento de la empresa
• Seguro de gastos médicos mayores
• Seguro de la vista
• Seguro dental
• Seguro de vida
• Vales de despensa

Experiencia:

• actividades de calibración en una industria regulada: 5 años (Obligatorio)
• creación y seguimiento de programas de calibraciones: 3 años (Obligatorio)
• creación y análisis de métricas clave : 3 años (Obligatorio)

Lugar de trabajo: Empleo presencial