Quality Engineer II

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 https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Ciudad Juarez, Chihuahua, Mexico

Job Description:

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 Quality Engineer II to be in Juarez City.

You will be responsible for:



* Primary responsibilities include assisting in a supporting role on new product development, sustaining and supply chain quality projects.

Assist in the development of effective quality control and associated risk management plans.


* Write 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).


* Help to ensure that development activities follow design control requirements, product is tested per applicable standards, European Essential Requirements are met per the MDR, and product is properly transferred to manufacturing.


* Provide support in quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction


* Assist in planning necessary to ensure effective product acceptance.

This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans.


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


* Support NC, CAPA, Internal Audit, Training and QS activities as needed and ensures compliance to all applicable due dates.


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

Qualifications / Requirements:


* Bachelor’s degree in a related field, along with minimum 2 – 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required.

Master’s degree is preferred


* American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.


* Familiarity of GD&T (Geometric Dimensioning and Tolerancing) conce...