Quality Engineer II (2nd Shift)

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 . 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. 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 ( 2nd Shift ) to be in Salvarcar Plant, Juarez, Chih.

Under general supervision, participate in new and sustaining 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. Supports quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. Will receive technical guidance on complex problems, but independently develops approaches and solutions. Work is usually well defined and is checked for progress and reviewed for accuracy upon completion. EXPERIENCE AND EDUCATION 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. Verbal and written communication skills and ability to effectively communicate with internal and external personnel Ability to develop and implement Quality standards. Some knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices. Some knowledge of or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies. Ability to apply project management skills to fulfill new product development requirements. Problem solving skills.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: 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