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, Chihuahua, 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 **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 STAFF QUALITY ENGINEER to be in Ciudad Juarez.** **Purpose:** Constructs critical Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer’s operational needs and requirements. Coaches team members regarding any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions. Oversees, under general direction, capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements. Confers with team members on process validations for current and new Quality Engineering processes for subsequent operational integration and supply chain implementation. Assist in establishing ongoing training of Quality Engineering Technicians, supporting and enforcing site-specific safety and industrial hygiene requirements. Ensures timely escalation of 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. **You will be responsible for** **:** In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: Business Improvement + Revision / analysis of the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and other improvement tools and programs. + Performs benchmarking to develop more effective methods to improve quality. + Establishes the metrics that are the quality indicators. + Provides support to the development of quality engineering and the compliance of the quality with the adequate abilities for the introduction of new products, and the management of the life cycle of the product. + Revises and approves the engineering change orders. (ECOs). + Establishes the categories of the quality costs and bases of the quality cost. Compliance / Regulatory + Revises / analyzes if the current products and processes (including actions or decisions performed) comply with the regulations, such as the QSRs, ISO 13485, etc, including providing support during internal and external audits. + Participates in preparation activities for/or interactions with regulatory agencies (FDA, JJRC, BSI, etc.). + Responds to internal or external audit observations related to the function of quality engineering. + Properly establishes and maintains the required documentation of quality assurance activities and/or quality systems. + Performs periodical audits in the line to evaluate GMPs, production controls, lot segregation and audits to the process according to JJPS. Revises the audit results of the area to ensure that the corrective and preventive actions are adequate. Finances + Controls and maintains the central budget of the department/cost. New Products / Process Introduction + Works with NPI and with the manufacturing, process engineering and manufacturing engineering departments to develop, conduct and approve product and process validation strategies. Product Quality, Control and Disposition and Performance Standards + Directs and attends to Revision meetings of NCs as member of the MRB. + Conducts or supports the investigations, bounding, documentation, revision and approval of the non-conformities (NCs), preventive and corrective actions (CAPAs), customer complaints and Escalation of quality problems when applicable. + Responsible and owner of the identification of material, material segregation, classification of the type of defects, including the successful application of these techniques in the day-to-day in manufacturing. + Analyzes/revises the effectiveness of the preventive and corrective actions.• + Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished product. + Provides support for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level. Product Grading / Process + Revises, approves, executes IQ, OQ, PQ, TMV or Software Validation. + Maintains and periodically checks the CTQs in the manufacturing process to guarantee the continuous satisfaction of the customer. + Develops, maintains and checks that the measuring methods are appropriate for the manufacturing process. + Provides support in the revision and maintenance of PFMEAs, Quality control plans, process instructions, and additional manufacturing documents. + Develops, interprets and properly implements process monitoring and control methods consistent with the risk level of the process/product. + Evaluates and interprets the causes of common vs special variation in the manufacturing process and determines the adequacy of the limits of the current processes. + Evaluates the need of risk mitigation techniques due to the product classification, potential types of defects, defect frequency, severity, patient risk, process capacity, process controls, etc. Determines the effectiveness of these techniques in the improvements previously implemented. + Responsible and owner of the risk assessment process including the realization, documentation, revision or maintenance of the current risk and documentation of the risk assessment such as FMEA of the process due to the changes in the product/process. Strategy + Collaborates with the quality leaders to identify the required quality engineering skills and competences that allow the execution of the strategic vision. People + Provides supervision, mentoring, coaching, performance revision, development plans and planning of the succession for others (when applies). + 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:** EXPERIENCE AND EDUCATION + As minimum, Bachelor, preferably in engineering: Mechanical, Electrical, industrial or applicable science. + 6 to 8 years of work experience or demonstrated performance. REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS + Use of computer packages. + Ability to communicate in English, orally and written. + Knowledge of product / process Risk Management (FDA and ISO regulations), preferably. + Advanced technical training and experience in the use of Statistics and Lean methodologies and Six Sigma, including Measuring System Analysis, SPC, DOEs, reliability, etc. + Strong knowledge of statistical software packages, preferably, with the capacity of pre-visualizing, create graphs and analyze data and be capable of presenting data that facilitates the taking of decisions. + Ability to perform an “active involvement” in the solution of problems and resolution of problems, preferably. + Capacity to solve problems and provide good judgment, highly desirable. + Demonstrated management abilities of projects and leadership projects, preferably. + Certifications such as CQA and CQE (preferably), CBA and Green Belt are a plus.