SENIOR CUSTOMER QUALITY ENGINEER

at  Johnson Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.
When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.
We are searching for the best talent for SENIOR CUSTOMER QUALITY ENGINEER to be in Juarez, Chih., in Plant Independencia.
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:

• Provides specific technical expertise to support product and process improvements. Provides technical input to project teams, such as R&D, CAPA, and coordinates protocols, Engineering studies and/or pilot, processes as required.
• Assists with implementation of applications for quality systems. Owner for key operational metrics for their particular product families.
• Responsible for ensuring that the NPD process with reference to the complaint analysis is transferred in a timely manner as it relates to the creation of ACs, investigation plans, and the execution of the protocol.
• Review and approve AC and investigation plan change requests for their assigned franchise. Ongoing interaction with the CAPA franchise for the product families assigned.
• Have knowledge of all quality related aspects pertaining to complaints for the assigned franchise (CAPAs, NCRs, etc.)
• Participate in the Rapid Respond teams for product families assigned. Assists in training engineers and technicians to complaint investigation process.
• Assists with implementation of Ethicon Franchise applications for quality systems.
• 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.

QUALIFICATIONS

Requirements:

• Bachelor of Science in Engineering or relevant experience. ASQ Quality Engineering Certification. recommended.
• 4-6 Years with BS in relate Field 5+ Years with MS, 1+ Years with PhD Approximate experience within a regulated medical device environment Complaint handling experience recommended.
• 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.
• 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.

• Provides specific technical expertise to support product and process improvements. Provides technical input to project teams, such as R&D, CAPA, and coordinates protocols, Engineering studies and/or pilot, processes as required.
• Assists with implementation of applications for quality systems. Owner for key operational metrics for their particular product families.
• Responsible for ensuring that the NPD process with reference to the complaint analysis is transferred in a timely manner as it relates to the creation of ACs, investigation plans, and the execution of the protocol.
• Review and approve AC and investigation plan change requests for their assigned franchise. Ongoing interaction with the CAPA franchise for the product families assigned.
• Have knowledge of all quality related aspects pertaining to complaints for the assigned franchise (CAPAs, NCRs, etc.)
• Participate in the Rapid Respond teams for product families assigned. Assists in training engineers and technicians to complaint investigation process.
• Assists with implementation of Ethicon Franchise applications for quality systems.
• 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