Job Information
J&J Family of Companies SENIOR SOURCE QUALITY ENGINEER (TEMPORARY 12 MONTHS) in Ciudad Juarez, Mexico
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 (https://www.jnj.com.) .
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.
Job Function:
Quality
Job Sub Function:
Supplier Quality
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
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 https://www.jnj.com/medtech
We are searching for the best talent for Senior Source Quality Engineer (Temporary 12 months) to be in Juarez Chih.
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:
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Provide leadership in design in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the products.
• Activities include driving correction, corrective action, prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
• Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
• Provide review and approvals for the release of new products ensuring quality requirements are met.
• Provide leadership & support to J&J process excellence initiatives including Six-Sigma, design excellence & lean thinking.
• Direct development & consistent application of quality policies & procedures in product design & development, secondary development, manufacturing, external manufacturers & suppliers.
• 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.
• 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.
Qualifications / Requirements:
Extensive validation experience is critical
Individual needs to be able to independently manage complex validations
This position may require significant travel, at times > 50% to Guadalajara
Bi-lingual – Spanish/English
Bachelor degree in engineering- mechanical, electrical, industrial, preferred, or Applicable science
CQE, CRE, CQA 2– Ratings, GB preferred.
Generally requires (4-6) years related experience
Required Skills:
Preferred Skills:
Business Alignment, Coaching, Compliance Management, Controls Compliance, Developing Others, Inclusive Leadership, ISO 9001, Leadership, Persistence and Tenacity, Quality Control (QC), Quality Processes, Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection, Workflow Analysis