senior quality engineer

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Ciudad Juarez, Chihuahua, Mexico

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology, we're 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

About Cardiovascular

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

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

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

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Senior Quality Engineer to be in Cd. Juárez, Chih. at Plant Salvacar

Purpose:

To perform various technical duties of quality control and quality assurance such as: establish inspection procedures and methods.

You will be responsible for:

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Monitor all FGQA quality assurance functions.

• Establish and maintain appropriate documentation as required for Quality Assurance activities and the Quality Documentation Systems.

• Develop statistical sampling plans and perform process capability studies.

• Implement process control systems and provide technical support for process validations.

• Provide QS support in Product transfers and new products development.

• Assist in training new engineers, train technicians and supervisors in process changes.

• Perform Complaint analysis investigation as needed.

• Participate in process/ quality improvement projects.

• Assist with implementation of EES applications for quality systems.

• Support COGs initiatives.

• Responsible for following and administering safety.

• Compliance with safety policies and procedures.

• Follow J&J and EES 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.

• Follow J&J and EES 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. Appendix I Rev 10 CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5

• Assist, review & approve non-conformances investigations & non-conforming product dispositions.

• Provide as needed, subject matter expert feedback on manufacturing process changes.

• Other responsibilities may be assigned and not all responsibilities listed may be assigned.

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• 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.

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Qualifications / Requirements:

• Bachelor's degree in engineering- mechanical, electrical, industrial, preferred, or Applicable science or business degree.

• CQE, CRE, CQA 2– Ratings, GB preferred.

• Generally requires (4-6) years related experience.

• Bilingual: English/ Spanish preferred.

• GMP/ ISO knowledge preferred.

• PC experience.

Cognitive/Behavioral Abilities:

• Ability to work in stressful/fast paced environment.

• Ability to work and interact with co-workers to accomplish company goals in a team environment.

• Management Skills.

• Analytical/Problem Solving Skills.

• Ability to communicate verbally and in writing

• Ability to learn.

Required Skills:

Preferred Skills:

Coaching, Consistency, Controls Compliance, Critical Thinking, Data Savvy, Engineering, Financial Competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, Lean Supply Chain Management, Leverages Information, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

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