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 jnj.com.
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**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 https://www.jnj.com/medtech
**We are searching for the best talent for Senior Quality Engineer (Temporary 12 months) to be in Juarez Chih. Ethicon Plant **
**Purpose: **The position of Senior Supplier Quality Engineer is responsible for support and leadership of Quality Engineering activities in of New Product Development, Ongoing Manufacturing – including resolution of nonconformances (root cause & corrective action), CAPA, Quality System and process improvement activities.
You will be responsible for:
• 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.
• 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
Qualifications / Requirements:
- Bachelor degree in engineering- mechanical, electrical, industrial, preferred, or Applicable science Extensive validation experience is critical
- Individual needs to be able to independently manage complex validations
- Bi-lingual – Spanish/English
- CQE, CRE, CQA 2– Ratings, GB preferred.
- Generally requires (4-6) years related experience
**Required Skills: **
Preferred Skills:
Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards