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
job function
quality
job sub function
quality assurance
job category
professional
all job posting locations:
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
we are searching for the best talent for staff quality engineer to be in juarez city.
you will be responsible for
* support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
* review/analyze the effectiveness of pdca, six sigma, kaizen, lean techniques and/or other improvement tools and programs.
* conduct benchmarking with external companies or internal sites to develop more effective methods for improving quality
* supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management. conducted) are in compliance to standards such as the qsrs, iso 13485, etc.
* champions compliance to applicable global regulations and standards (e.g. Qsrs, iso, en and medical device directive (mdd) requirements) including providing support during internal and external audits.
* conduct periodic line audits to assess for production controls such as lot segregation.
* review results of area audits to ensure that corrective and preventive actions are adequate.
* conduct investigation, bounding, documentation, review and approval of nonconformances, capas and customer complaints. Escalation of quality issues as appropriate.
* accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
* analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
* accountability and ownership of quality metrics including maintenance and reviewing of leading and lagging indicators of qa
* partners with j&j global supply chain, finished goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
* conduct stakeholder analysis to ensure that customer ctqs are known and adequate addressed in control plan
* develop measurement systems/capabilities, destructive tests, non-destructive tests for manufacturing processes
* develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
* develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
qualifications / requirements
* this position will require relevant experience working in manufacturing/operations.
* a minimum of a bachelor's degree, preferably in engineering or related technical field.
* from 6-8 years related experience
* experience working in both an fda and european regulatory environment is preferred.
* experience with implementation of risk mitigation is preferred.
* knowledge of product/process risk management (fda and iso standards) is required.
* knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making
* technical training and experience using statistics, lean and six sigma methodologies is preferred including measurement system analysis, spc, does, reliability, etc.
* the ability to perform "hands on" troubleshooting and problem solving is preferred. Decision making based on standards, requirements, procedures and quality knowledge gained with experience.
* communication of quality issues, escalations and investigations to different levels.
* good technical understanding of manufacturing equipment and processes is required.
* understanding of the npi (new product introduction) process and process validation expertise is preferred.
* a thorough understanding of gmp/iso regulations and validation regulations is preferred.
* demonstrated project management and project leadership abilities are preferred.