Staff Quality Engineer

OverviewAt 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.comJob DetailsJob Function: QualityJob Sub Function: Quality AssuranceJob Category: ProfessionalAll Job Posting Locations: Ciudad Juarez, Chihuahua, MexicoJob DescriptionAbout MedTechFueled 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/medtechAbout CardiovascularFueled 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/medtechStaff Quality Engineer – Location: Juarez, ChihuahuaPurposeThe Quality Engineer Staff plans or adapts the new methods or procedures to control or coordinate all aspects of several projects at the same time and in the solution of related and technical projects. The engineer Staff is an emergent authority in a specific technical field, exercising a considerable freedom in the determination of the technical objectives of the assignments. The work typically results in the development of new or improved methods to reduce risks, equipment, materials, processes, products and technical methods. The Engineer Staff acts as a mentor for lower hierarchy personnel and provides advice to upper management about technical matters. The Quality Engineer Staff will use tools and quality engineering practices for the effective and efficient development of transfers and maintenance of products / processes in the whole life cycle of the product. The holder will also use quality engineering principles and investigation skills for the resolution of complex problems (technically) associated to the manufacturing process at a local or franchise level, including those related to escalations. He/she will use risk management to prevent failure modes and improve process capacity. This person will provide support to the business process and supervisor or direct technicians.You Will Be Responsible ForUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:Business ImprovementRevision / 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 / RegulatoryRevises / analyzes if the current products and processes comply with regulations (e.g., QSRs, ISO 13485), including providing support during internal and external audits.Participates in preparation activities for interactions with regulatory agencies (FDA, JJRC, BSI, etc.).Responds to internal or external audit observations related to quality engineering.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; ensures corrective and preventive actions are adequate.FinancesControls and maintains the central budget of the department/cost.New Products / Process IntroductionWorks 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 StandardsDirects and attends revision meetings of NCs as a member of the MRB.Conducts or supports investigations, bounding, documentation, revision and approval of non-conformities (NCs), CAPAs, customer complaints and quality problem escalations when applicable.Responsible for identification of material, material segregation, defect classification, and applying these techniques in day-to-day manufacturing.Analyzes/revises the effectiveness of CAPAs and NCs.Defines sampling plans and approves inspection methods for evaluation and acceptance of components and finished products.Provides support for resolution of complex manufacturing process problems at a local or franchise level.Product Grading / ProcessRevises, approves, and executes IQ, OQ, PQ, TMV or Software Validation.Maintains CTQs in manufacturing to guarantee ongoing customer satisfaction.Develops and maintains measuring methods for the manufacturing process.Supports PFMEAs, Quality Control Plans, process instructions, and related manufacturing documents.Develops and implements process monitoring and control methods aligned with process risk level.Evaluates causes of common vs. special variation and adequacy of process limits.Assesses risk mitigation techniques based on product classification and defect considerations.Manages risk assessment and documentation (e.g., FMEA) for product/process changes.StrategyCollaborates with quality leaders to identify required quality engineering skills and competencies to execute the strategic vision.PeopleProvides supervision, mentoring, coaching, performance reviews, development plans, and succession planning where applicable.Communicates business-related issues to the next management level.Ensures staff compliance with Health, Safety and Environmental practices and availability of resources as needed.Ensures compliance with all regulations, policies, and procedures.Performs other duties as needed.Qualifications / RequirementsMinimum: Bachelor’s degree, preferably in engineering (Mechanical, Electrical, Industrial or applicable science).6 to 8 years of experience or demonstrated performance.Proficiency with computer software packages.Ability to communicate in English (oral and written).Knowledge of product/process risk management (FDA and ISO regulations) preferred.Advanced technical training and experience in statistics, Lean methodologies, Six Sigma (including MSA, SPC, DOEs, reliability).Strong knowledge of statistical software; ability to visualize, graph data, and present data to support decisions.Ability to actively participate in problem resolution; strong judgment and leadership in project management preferred.Certifications such as CQA and CQE (preferable), CBA and Green Belt are a plus.Required SkillsPreferred Skills: Agility Jumps, Analytical Reasoning, Analytics Dashboards, Coaching, Collaboration, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, System Audits, Systems Analysis #J-18808-Ljbffr