Senior Quality Engineer

Senior Quality Engineer – Johnson & Johnson Med Tech

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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 Med Tech, 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

• Cincinnati, Ohio, United States of America
• Danvers, Massachusetts, United States of America
• Irvine, California, United States of America
• Raritan, New Jersey, United States of America

J&J Med Tech is recruiting for a Senior Quality Engineer located in Cincinnati, OH.

The role of a Senior Quality Engineer at J&J Med Tech is to apply the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo:

• Meet and exceed the expectations of our customers
• Achieve and maintain compliance with regulatory expectations

The Senior Quality Engineer provides overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of Johnson & Johnson products, and ensures compliance to Good Manufacturing Practices, International Organization for Standardization, and any other applicable standards. Depending on job needs, a Senior Quality Engineer may work in one or more of the following areas:

• New product development / new product introduction / new process introduction
• Supply chain (life‑cycle engineering, manufacturing, assembly, or supplier quality)
• Quality systems and business processes

• Provides leadership in design and implementation of world‑class quality engineering to support the entire product life cycle with focus on reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product.
• Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady‑state manufacturing processes; acts as technical liaison, as needed, between product development, manufacturing, external manufacturers, and suppliers.
• Reviews and edits all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation; provides review and approval for the release of new products and design changes ensuring quality requirements are met.
• Applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments.
• Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.
• Addresses and corrects product and process complaints through data analysis, continuous product improvement, and/or corrective and preventive actions.
• Communicates business‑related issues or opportunities to next management level.
• Oversees audits of quality system categories to assess compliance to process excellence standards.
• Ensures comprehensive measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct and prevent defects, presenting reports to management which outline findings.
• Performs and/or oversees complex hands‑on and simulated testing for design verification and test method developments; inspects and oversees testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications.
• Studies specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to…