SENIOR QUALITY ENGINEER

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, 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 Senior Quality Engineer to be in Salvarcar Plant, Ciudad Juarez, Chih.

Purpose: Participate in new 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.Drive quality assurance activities intended to ensure effective product quality processes are in place and executed throughout lifecycle of product. May receive technical guidance on complex problems, but independently determines and develops approaches and solutions.

Shares technical expertise with others and helps develop junior level engineers.

Qualifications / Requirements

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

Primary responsibilities include working in Quality Engineering and with other functional groups in support of new product/process development, quality operations or quality assurance.

Utilizing Quality Engineering tools/processes in development and implementation of practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle.

Leading efforts with quality improvement opportunities as appropriate to legacy products, continuous improvement, and customer satisfaction.

Develop and establish effective quality control and support associated risk management plans.

Write, review and/or approve 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).

Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products.

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 all planning necessary to ensure effective product acceptance. This includes, but is not limited to:

Part qualifications

Specification development

Sampling plans

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

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

Assist in complaint analysis as appropriate.

Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new processes/devices as necessary.

Participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.

Makes decisions independently on engineering problems and methods and represents the organization in conferences to resolve important questions and to plan and coordinate work.

Consults with supervisor and provide guidance as needed concerning unusual problems and developments.

Responsible for one or more of the following as needed:

Supervise and/or provide guidance to Inspectors and Technicians in Quality LCM, Quality Operation or Quality Assurance activities. o In a supervisory capacity, plans, develops, coordinates, and directs a medium-sized engineering project or a number of small projects with varying levels of complexity.

As an individual researcher, carries out assignments requiring the development of new or improved techniques or procedures.

Work is expected to result in the development of new or improved techniques or procedures. o Work is expected to result in the development of new or refined equipment, materials, processes, products, and/or methods.

Assesses the feasibility and soundness of proposed engineering evaluation tests, products or equipment, when necessary, data are insufficient or confirmation by testing is advisable.

Additional responsibilities:

Responsible for communicating business related issues or opportunities to next management level. o 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. o Performs other duties assigned as needed.

You will be responsible for:

Bachelor’s degree in a related field, along with a minimum of 4 – 6 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.

Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is desirable.

Ability to develop and implement Quality standards.

Thorough knowledge of Quality and operations systems and processes, including GMP and QSR requirements for medical devices.

Thorough knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools and methodologies.

Ability to apply project management skills to ensure fulfillment of new product development requirements.

Demonstrated auditing and problem-solving skills.

Understanding of Six Sigma and Business Excellence tools and methodologies.

Lean manufacturing experience desirable.

Ability to train and mentor a diverse array of employees on quality topics.

Good understanding of theoretical and practical fundamentals and experimental engineering techniques.

Required Skills:

Preferred Skills:

Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy