At Johnson acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers * Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met * Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
In addition, applies relevant regulations, standards, and industry best practices to assignments.
* Plans and conducts projects and assignments with technical responsibility or strategic input.
Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.
* Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions * Communicates business related issues or opportunities to next management level * Oversees audits of quality system categories to assess compliance to process excellence standards * Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings * Performs and/or oversees complex hands-on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications * Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures,



and cost * Ensures personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures * May support technical training (i.e. statistics and quality methods) and teaching/mentoring of others + 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: * A bachelor's degree in engineering from an accredited engineering or relevant science/technical school is required.
A degree in Mechanical, Electrical, or Biomedical Engineering or other equivalent technical degree is preferred.
* Non-STEM graduates with follow-on technical training or experience will also be considered.
Appropriate relevant advanced degrees are preferred.
* Generally requires minimum of 4 years' work experience.
Experience in a regulated industry (medical technology, pharmaceutical, or biotechnology) or veterans with leadership experience will be given preference.




* Experience with Risk Management (ISO *****), Medical Device Quality Management System (ISO *****), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is strongly preferred * Auditing skills such as - ISO, QSR (Quality Systems Regulations), MDSAP, and GMP standards are preferred * An ASQ certification (CQE, CQM, CRE or CQA) is an asset.
Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset * Candidates must be fluent in English, for both written and oral communication * Candidate must have strong analytical problem-solving skills and be able to contribute to or lead root cause investigations using various problem solving techniques and tools, and assess effectiveness of corrective actions * Candidate must have sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
* Experience with project management and the ability to work with multiple simultaneous priorities in a highly matrixed environment is required; ability to work cross-culturally is also highly valued * Demonstrated experience working within a team, obtaining feedback, negotiating, and positively influencing is required * Ability to understand new concepts quickly, research and maintain ongoing learning of industry regulations is required * Fundamental technical understanding of manufacturing equipment and processes is required * Prior experience working with Risk Analysis and Risk Management is also preferred * Advanced quality systems (AQS) experience preferred * Knowledge of: Regulatory compliance, GMPs, MDR (Medical Devices Regulation), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry

📌 Senior Quality Life Cycle Engineer (Ciudad Juárez)
🏢 Johnson & Johnson
📍 Ciudad Juárez