Sr Quality Engineer - Shockwave Medical - Santa Clara California

Company: Johnson & Johnson
Location: Santa Clara, California
Posted On: 02/04/2025

Job Description - Sr Quality Engineer - Shockwave Medical (2406226157W)Johnson & Johnson is recruiting for a Sr Quality Engineer for Shockwave Medical Inc. located in the United States.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. Learn more at .Position Overview:The Sr. Quality Engineer will support manufacturing and work cross-functionally to resolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, including those related to verification or validation activities, determines criteria and subsequently generates summary (or final) reports.Essential Job Functions:

• Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
• Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
• Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, and product defect investigations. Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence.
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
• Independently performs most assignments with an understanding of the overall expectations. Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
• Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project.
• Performs work which involves conventional engineering practice but may include a variety of complex features such as conflicting design requirements, unsuitability of conventional materials, and difficult coordination requirements.
• Work requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties. Familiarity with FDA guidance documents and ISO and ASTM standards related to quality and medical device industry is an asset.
• Independently assesses if components, sub-assemblies, products meet specification and can initiate, investigate and resolve non-conformances by working in conjunction with a multidisciplinary team.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• May participate in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes, and ensure the process has adequate and appropriate process controls.
• May technically supervise or coordinate the work of engineers, technicians, and others who assist in specific assignments.
• May conduct internal and supplier audits. Certified as a lead auditor in ISO13485:2016 would be an asset.
• Processing, investigating, and completing customer complaints, which could require direct email responses to customers.
• Composes technical complaint reports timely and accurately based on reported information and device investigation data.
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