Customer Quality Engineer I (Fixed Term 12 Months)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at Surgery

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for Customer Quality Engineer I (FIXED TERM 12 MONTHS)

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 MDRs 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 assignedfranchise.

• Participate in process/ quality improvements projects.

Qualifications / Requirements:

• Bachelor of Science in Engineer

• 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.

• 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

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Preferred Skills: