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

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:

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.

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 QUALITY ENGINEER (Fixed Term 18 months) for Planta Salvarcar in Ciudad Juarez.

Purpose:

Participate in new product/process teams to develop quality-engineered systems and products, lead and support design verification tests, process validations, quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices. Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level engineers.

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:





- Primary responsibilities include working in Quality Engineering and with other functional groups in support of new product/process development, quality operations or quality assurance.

- Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.

- Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.

- Develop and establish effective quality control and support associated risk management plans.

- Write, review and/or approve process and product validation protocols and reports, equipment qualifications, engineering change orders.

- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).

- Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.

- Requirements are met per the MDR, and product is properly transferred to manufacturing.

- Provide all planning necessary to ensure effective product acceptance. This includes, but is not limited to, part qualifications, specification development, and sampling plans.

- Support vendor audits as technical lead as needed and support Supplier Quality as Quality representative as appropriate.

- Initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate.

- Assist in complaint analysis as appropriate.

- Assist Regulatory Affairs in developing submissi

📌 SENIOR QUALITY ENGINEER (Ciudad Juárez)
🏢 Johnson & Johnson Innovative Medicine
📍 Ciudad Juárez