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:** Alajuela, Costa Rica **Job Description:** **Johnson & Johnson is hiring for a** **Sr. Supplier Quality Engineer** **to join our team located in** **Shockwave Medical Costa Rica.** **Position Overview** **The Sr. Supplier Quality Engineer performs work with general supervision to provide and implement solutions to broad problems and accomplishes complex assignments. The scope of responsibilities includes supporting manufacturing operations, managing suppliers, and working with cross-functional groups to address quality issues. The Sr. Supplier Quality Engineer participates in decisions related to scope of work, risk management, process improvements, material disposition, and the implementation of revised product specifications.** **Essential Job Functions** **Supplier Management o Partner with Procurement, R&D, Operations, Quality, and Suppliers in the timely investigation, resolution, and prevention of supplier quality issues which could disrupt business operations** **Monitor and analyze supplier performance metrics, identify improvement opportunities, and communicate supplier risks and/or opportunities to the next management level** **Plan, schedule, execute, report, and follow-up on supplier audits** **Initiate, issue, review, and approve Supplier Corrective Action Reports (SCARs) Drive corrective actions for supplier processes by driving suppliers to true root cause analysis and corrective and preventive actions o Own, manage, and drive to completion Supplier Change Assessments (SCAs) o Participate in component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups o Compile, analyze, and summarize supplier performance data for periodic management reviews** **Manufacturing Support o Review, investigate, disposition, and drive to completion Non-conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs) o Initiate, review, and approve Document Change Orders (DCOs) o Provide technical support and guidance to the Quality Assurance group o Support internal and third-party audits (FDA, Notified Body) o Participate in Material Review Board (MRB) meetings** **Manufacturing Line Transfers** **Partner with cross-functional teams to define requirements and generate documentation for the transfer of manufacturing lines to Contract Manufacturers (CMs)** **Plan and provide on-site and off-site training to CMs on product inspection and testing** **Act as the primary Quality point of contact with CMs, and provide remote and off-site support on matters related to Quality** **Other duties as assigned** **Requirements** **BS degree in a related engineering discipline and 5+ years of relevant experience, or MS degree in a related engineering discipline and 3+ years of relevant experience** **Experience in the medical device industry is strongly preferred** **Strong understanding of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems** **Strong technical writing skills** **Effective communication skills across all levels of the organization** **Must be proactive, self-motivated, and able to work independently with minimal supervision** **Ability to work independently in a fast-paced environment while managing multiple priorities** **Experience in statistics (hypothesis testing, capability analysis, DOE, MSA, Gage R&R), Six Sigma, Lean** **Certifications (CQE, Lead Auditor, Six Sigma, Project Management) would be a plus** **Able to lift objects weighing up to 25 lbs** **Ability to travel up to 10% of the time** **Fluent in English and Spanish** **Required Skills:** **Preferred Skills:** Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy