CUSTOMER QUALITY ENGINEER I (24 Months)

at  Johnson Johnson

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We are searching for the best talent for CUSTOMER QUALITY ENGINEER I (24 Months) to be in Juarez, Chihuahua in Independencia plant
Purpose: To provide support to customer complaint investigation and analysis process for the Ethicon Franchise.
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 will be responsible for the following:

• Follow all company safety policies and other safety precautions within the work area Compliance with safety policies and procedures.
• Follow J&J and Ethicon Franchise Records Management Policies for Convenience Information.
• Records Retention Schedules, Training and Education, Document Hold Notices.
• Records Cleanout, Inactive Records and Information Management, Vital Records, and third-party vendor if applicable.
• Responsible for following and administering QSR policies and procedures, and ISO Standards.
• If assigned as department records coordinator responsibilities per applicable procedures.
• Compliance with Environmental Management System(EMS) and Good Lab Practices(GLP)
• 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.
• Ensures timely reporting of Product Investigations, MDR’s, Weekly/Monthly reports and Product Investigation status update is current in the network.
• Ensures all necessary tools and equipment are available
• Performs and schedules resources for Product Complaint Analysis.
• Assists with complaint analysis and failure investigations daily and documents analysis results and information for Med Watch Reports on all product families assigned.
• Provides support in product transfers and new products development, as required. Assists in training new associate Engineers or technician to complaint investigation process.
• Initiates AC and investigation plan change requests process for their assigned franchise. Participate in process/ quality improvements projects

QUALIFICATIONS

• Bachelor of Science in Engineering or relevant experience.
• 0-2 Years with BS in related Field
• 0+ Years with MS Approximate experience within a manufacturing environment(medical device environment preferred.)
• Bilingual: English/ Spanish required.
• QSR/ISO knowledge preferred.
• Technical writing skills for Customer Letters required.
• Knowledge of risk management required.
• Failure investigation tools knowledge preferred.
• Strong Communications skills required.x|
• Analytical required.
• Medical device product knowledge preferred.
• Product Complaint experience preferred.
• Proficient in word processing, spreadsheet, presentation, database applications.
• Statistical Analysis Software.
• Knowledge of EES information systems such as Electronic Complaint system, AQR, NC, CAPA, Audit and ERP preferred.

• Follow all company safety policies and other safety precautions within the work area Compliance with safety policies and procedures.
• Follow J&J and Ethicon Franchise Records Management Policies for Convenience Information.
• Records Retention Schedules, Training and Education, Document Hold Notices.
• Records Cleanout, Inactive Records and Information Management, Vital Records, and third-party vendor if applicable.
• Responsible for following and administering QSR policies and procedures, and ISO Standards.
• If assigned as department records coordinator responsibilities per applicable procedures.
• Compliance with Environmental Management System(EMS) and Good Lab Practices(GLP)
• 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.
• Ensures timely reporting of Product Investigations, MDR’s, Weekly/Monthly reports and Product Investigation status update is current in the network.
• Ensures all necessary tools and equipment are available
• Performs and schedules resources for Product Complaint Analysis.
• Assists with complaint analysis and failure investigations daily and documents analysis results and information for Med Watch Reports on all product families assigned.
• Provides support in product transfers and new products development, as required. Assists in training new associate Engineers or technician to complaint investigation process.
• Initiates AC and investigation plan change requests process for their assigned franchise. Participate in process/ quality improvements project