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 https: //www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Ciudad Juarez, Mexico

Job Description:

Identifies improvement opportunities for Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements. Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions. Examines capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements. Performs process validations on current and new Quality Engineering processes for subsequent operational integration and supply chain implementation. Facilitates supervision of Quality Engineering Technicians by supporting and enforcing site-specific safety and industrial hygiene requirements. Communicates and escalates in a timely manner, any Quality Engineering issues or concerns to the next management level. Coaches more junior colleagues in techniques, processes, and responsibilities.​ Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

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

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

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 Ciudad Juarez, Mexico.

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.

RESPONSABILITIES:

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

Appendix I 100612422 Rev M CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5

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,

and 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:

o 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.

o As an individual researcher, carries out assignments requiring the

development of new or improved techniques or procedures.

o 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.

o 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.

o 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

o 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

EXPERIENCE/ EDUCATION/ QUALIFICATIONS:

• Bachelor’s degree in a related field
• 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.