TECNICO SENIOR CUMPLIMIENTO DE MANTENIMIENTO Y CALIBRACION
J&J Family of Companies
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We are searching for the best talent for SENIOR COMPLIANCE TECHNICIAN FOR MAINTENANCE & CALIBRATION to be in Juarez, Chih. Salvarcar Plant
Purpose:
Support on planned and unplanned audits, verifying compliance with government regulations and applicable standards, in addition to company policies and procedures. Provides support during the preparation and execution of internal and external audits. Responsible to elaborate metrics with KPIs by quality system. Prepare pre-requisites, organizes information, and follow up actions generated as part of the internal and external audits for Maintenance and Calibration department.
You will be responsible for:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
+ Ensures that Quality System Audits comply with QSR/GMP/GDP requirements, ISO Standards and regulations that apply to the Calibration and Maintenance department.
+ Conducts internal periodic review for Maintenance and Calibration reports/certificates.
+ Conducts Good Laboratory Practice (GLP) as required.
+ Gives guidance or advice to Maintenance and Calibration personnel regarding compliance with applicable standards and regulations.
+ Follows Action Plans, Effective Monitoring, and Investigations as result per Quality Systems Audits, Non-conformances, CAPAs and related.
+ Occasionally Leads audits as SME of Calibration and Maintenance department.
+ Keeps changes through publications, participation in seminars or through collaboration with organizations abreast of applicable standards for Maintenance and Calibration department.
+ Interprets Maintenance and Calibration records.
+ Domain Maintenance, Calibration and Maximo system procedures.
+ Follows Good Manufacturing Practices procedures (GMPs) and Good Documenting Practices (GDPs)
+ Applies the regulations stated by the metrology international standards such as ISO 17025, ISO 10012, Guide 25, ANSI and others.
+ Responsible for communicating business related issues or opportunities to next management level.
+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
+ Performs other duties assigned as needed.
**Qualifications**
Qualifications:
+ Technical Studies: Electromechanical, Instrumentalist, Maintenance related field. Bachelor’s Degree in Engineering or related areas (desirable)
+ Minimum 5 years of experience with standards regulations related to Instrumentation, Metrology, Calibration, Maintenance, and others (desirable)
+ Experience required on service, maintenance, equipment/process engineering, areas around manufacturing site with GMP products.
+ Ability to communicate complex situations in simple terms.
+ Anticipates and appropriately handles conflict situations.
+ Leads implementation of solutions to complex situations or problems.
+ Effective communication skills – oral and written – (English and Spanish)
+ Analytical skills to interpret scientific and technical publications as legal documents also.
+ Skills to present information effectively to senior management and public groups.
+ Skills for the use of computers and associated systems (software, e.g., MS Office).
+ Skills to interact with auditors by the government and independents.
+ Skills and knowledge of methods and techniques related to quality, including audit principles and techniques, quality terminology, quality management principles and their applications, as well as quality management tools and their applications.
+ Knowledge in problem-solving techniques.
+ Advanced knowledge of Metrology International Regulations.
+ Reading and interpretation of mechanical and electrical blueprints (desirable).
+ Knowledge on statistical tools and data analysis for interpretation is mostly preferred.
+ Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) is required as well as Minitab, eCMMS, EtQ compliance system etc.
+ Knowledge on maintenance System management (eCMMS) expertise is preferred.
+ Ability to work under pressure
+ Teamwork ability.
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