Quality Engineer II (2nd Shift)

Johnson & Johnson MedTech; Ciudad Juárez; Presencial; MXN 300.000 - 540.000; Jornada completa

Descripción de la vacante

Johnson & Johnson MedTech in Juarez, Chihuahua invites a Quality Engineer II (2nd Shift) to join the Salvarcar Plant. You will participate in new and sustaining product/process teams, develop quality-engineered systems, and support design verification tests and process validations.

You will ensure compliance with FDA, ISO 13485, CMDCAS, PMDA and other requirements, apply Six Sigma/ SPC tools, and help drive continuous improvement across lifecycle.

Formación

• Bachelor’s degree in a related field required.
• 2–4 years of quality, manufacturing, or R&D experience in a medical device or regulated industry.

Responsabilidades

• Assist in developing effective quality control and risk management plans for new product development, sustaining, and supply chain quality projects.
• Write process and product validation protocols and reports, equipment qualifications, and engineering change orders.
• Use statistical tools to analyze data, make acceptance decisions, and improve process capability.

Conocimientos

Customer Centricity

Data Savvy

Process Improvements

Quality Standards

STEM Application

Supervision

Supply Planning

Execution Focus

Quality Control Testing

Quality Systems Documentation

Document Management

Lean Supply Chain Management

Educación

Bachelor’s degree in a related field

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, 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.

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.
• 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.

Duties & Responsibilities

• 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.
• 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 communicating business related issues or opportunities to next management level
• 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

Customer Centricity, Data Savvy, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Issue Escalation, Lean Supply Chain Management, Process Control, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy