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

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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 Surgery

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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

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 Staff Quality Engineer to be in Cd. Juarez in plant Independencia.

Purpose:

Develops standard operating procedures, specifications, and provides technical transfer and validation support. Minimizes sample and scrap waste, assesses reliability and risks based on validated data, identifies root causes of problems, and reduces or eliminates sources of variation. Audits and approves manufacturing, quality, engineering and validation documents for conformance to business practices and departmental procedures. Provides data and documentation in support of the development of validation strategies. Acts as liaison to the regulatory affairs department to perform initial regulatory review of all engineering changes and modifications to products. Provides sampling plans and approves inspection methods for evaluation and testing of components and products. Provides support and expertise in reliability planning and reliability growth demonstration during new product development.

You will be responsible for:

The Quality Engineer utilizes Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality requirements and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
Business Improvements

• 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.

Compliance/Regulatory

• Review/analyze whether current product and processes (including actions or decisions 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.

New Product/Process Introduction

• Partners with R& D and other cross functional partners to ensure the proper application o design controls, risk management and the investigation/correction of desig failures/challenges.
• Supports the development of quality strategies related to the transfer of products, materials and components within J& J or externally. Supports new product introduction as part of design transfer.

People

• As applicable, provides supervision, mentoring, coaching, performance review, and developmental plans for others

Product Quality, Control & Disposition and Performance Standards

• 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 quality
• Product/Process Qualification
• Approve IQ, OQ, PQ, TMV or Software Validation

Production/Process Controls including Control Plans

• 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 adequately 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.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop, interpret and implement standard and non-standard sampling plans
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Accountability and ownership for sampling plans of all types including acceptability of risk given the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. including assessing, applying and interpreting acceptance sampling standard for manufacturing data.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.

Risk Mitigation

• Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
• Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
• Ownership and accountability of risk assessment process including conducting, documenting, reviewing or maintaining current risk and hazard analysis documentation such as Process FMEAs given product/process changes

Strategic

• Conduct strategic planning with site leaders and Product Engineering Team. Partnership with other functions to establish business priorities and resource allocation
• Ensures effective quality strategies are created for the validation of test methods, process and design.

• 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 procedure.

Qualifications / Requirements:

• Bachelor’s Degree.
• Highly Recommended related technical field.
• From 6-8 years related experience.
• The Staff Engineer devises or adapts new methods or procedures to control or coordinate all aspects of several projects simultaneously and in the solution of technical and related projects. The staff engineer is an emerging authority in a specific technical field, exercising considerable latitude in determining technical objectives of assignments. Work is generally expected to result in the development of new or refined methods to reduce risk, equipment, materials, processes, products and or technical methods. They conduct and track quality investigations and process deviations and follow up to ensure corrective action has been taken.
• Maintain active communication with sister plants as needed. Complies and writes training material and conducts training sessions on quality control activities/topics. Lead implementation of continuous improvement projects or act as subject matter expert for inspection and testing techniques.
• 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.
• Knowledge and experience in the areas listed in the Duties and Responsibilities associated with the
• position.
• Demonstrated project management and project leadership abilities are preferred.