Senior Source Quality Engineer (Temporary 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 Cardiovascular

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 Cardiovascular Ready to join a team thats 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 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

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