Quality Engineer II

8286-Cordis De Mexico Legal Entity; Ciudad Juárez; Presencial; MXN 420.000 - 640.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Juarez, Mexico is seeking a Quality Engineer II to join its MedTech quality team. Under general supervision, you will support design verification tests, process validations, and QA activities to ensure compliance with FDA, ISO 13485, and MDR requirements.

The role emphasizes problem solving, data analysis, and collaboration with suppliers and manufacturing teams to deliver safe, effective medical devices throughout product lifecycle.

Formación

• Bachelor’s degree in a related field with 2–4 years of quality, manufacturing, or R&D in medical devices.
• ASQ certification, Six Sigma experience, and GD&T knowledge desirable.
• Experience applying quality systems in regulated environments (FDA, ISO 13485, QSR).

Responsabilidades

• Support new product development, sustaining, and supply chain quality projects.
• Write validation protocols and reports; perform equipment qualifications.
• Use statistics to analyze data, make acceptance decisions, and improve process capability.
• Ensure compliance with design control, MDR, and regulatory requirements; assist in CAPA activities.
• Coordinate with Regulatory Affairs on submissions for process changes and new devices.

Conocimientos

Problem solving

Verbal communication

Written communication

Educación

Bachelor's degree in related field

Master's degree preferred

Descripción del empleo

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, 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 to be in Horizontes Plant, Juarez, Chih.

Job Summary

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. 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) concepts is desirable. 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.
• Verbal and written communication skills and ability to effectively communicate with internal and external personnel.

Duties & Responsibilities

• 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.
• Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.
• Moderate exercise of judgment is required on details of work and in making selections and adaptations of engineering alternatives.
• Supervisor or Sr./Staff/PMgr screens assignments for unusual or difficult problems and reviews techniques and procedures to be applied on non-routine work.
• Receives general direction on new aspects of assignments.
• Performs work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates, if applicable, follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.
• 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.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Performs other duties assigned as needed.

Required Skills: Preferred Skills: 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 https://www.jnj.com/.

Do Not Sell or Share My Personal Information Limit the Use of My Personal Information