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:
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:
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 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.
Appendix I 100612422 Rev M CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5
Assist in complaint analysis 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
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.
Root Cause Analysis (RCA)
Solving problems with a risk-first mindset
Ensuring and complying with the quality system requirements defined by internal procedures
Development, review and approval of protocols and reports for validations
Support the implementation of process and equipment validation activities (IQ, OQ, PQ, TMV, CSV)
Technical knowledge in manufacturing processes (Medical devices is a plus)
English 80%
**Required Skills: **
Preferred Skills: