Senior Quality Engineer

**Job Function**:Supply Chain Engineering**Job Sub Function**:Quality Engineering**Job Category**:Scientific/Technology**All Job Posting Locations**:Ciudad Juarez, MexicoIdentifies improvement opportunities for Quality Engineering Supply Chain project plans, key milestones, and objectives, to ensure deliverables are aligned with customer's operational needs and requirements.Identifies, under limited supervision, any Quality Engineering non-conformance, subsequent corrective, and preventive actions, by documenting, investigating, and conducting root cause analysis, and successfully implementing corrective actions.Examines capital and expense forecasts for assigned Quality Engineering projects, to ensure outputs adhere to quality, safety, and regulatory compliance requirements.Performs process validations on current and new Quality Engineering processes for subsequent operational integration and supply chain implementation.Facilitates supervision of Quality Engineering Technicians by supporting and enforcing site-specific safety and industrial hygiene requirements.Communicates and escalates in a timely manner, 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.**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.**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.**We are searching for the best talent for SENIOR QUALITY ENGINEER to be in Ciudad Juarez, Mexico.****PURPOSE**:Participate in new product/process teams to develop quality-engineered systems andproducts, lead and support design verification tests, process validations, qualityprocesses to ensure compliance with the company's Quality System policies andprocedures and applicable external requirements and standards, including FDA, ISO*****, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & JohnsonEnvironmental, Health & Safety Practices, and other applicable standards as pertains tomedical devices.Drive quality assurance activities intended to ensure effective productquality processes are in place and executed throughout lifecycle of product.May receivetechnical guidance on complex problems, but independently determines and developsapproaches and solutions.Shares technical expertise with others and helps developjunior level engineers.**RESPONSABILITIES**:In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson& Johnson, procedures and guidelines, this position:- Primary responsibilities include working in Quality Engineering and withother functional groups in support of new product/process development,quality operations or quality assurance.- Utilizing Quality Engineering tools/processes in development andimplementation of practices for the effective and efficient development,transfer, and maintenance of products/processes throughout the productlifecycle.- Leading efforts with quality improvement opportunities as appropriate tolegacy products, continuous improvement, and customer satisfaction.- Develop and establish effective quality control and support associated riskmanagement plans.- Write, review and/or approve process and product validation protocols andreports, equipment qualifications, engineering change orders.- Use statistical tools to analyze data, make acceptance decisions, andimprove process capability (Six Sigma, SPC, DOE).- Determine sterility, biological and packaging test requirements utilizingappropriate industry or agency standards for new products.- Ensure that development activities follow design control requirements,product is tested per applicable standards, European EssentialAppendix I ********* Rev M CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5Requirements are met per the MDR, and product is properly transferred tomanufacturing.- Provide all planning necessary to ensure effective product acceptance.Thisincludes, but is not limited to, part qualifications, specification development,and sampling plans.- Support vendor audits as technical lead as needed and support SupplierQuality as Quality representative as appropriate.- Ini