J&J Family of Companies Senior Quality Engineer, New Product Development Robotics in Cincinnati, Ohio
The Ethicon Surgical Care business a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Quality Engineer located in Cincinnati, OH.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
You, the Senior Quality Engineer will be responsible for support and leadership of Quality Engineering activities in, New Product Development, Life Cycle Engineering, CAPA, and process improvement activities for surgical instruments used in conjunction with surgical robotics systems.
Provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product. Activities would drive prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction.
Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
Provide review and approval for the release of new products ensuring quality requirements are met provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking.
Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
Lead QE for design verification test equipment validation efforts to include hardware and software aspects.
A minimum of a bachelor’s degree is required. A degree in engineering or other equivalent technical degree is preferred. An advanced degree is an asset.
A minimum of 4 years of experience in medical device, pharma or another highly regulated industry is required.
Knowledge of Quality Engineering/Scientific methods and techniques is required.
Experience with Risk Management (ISO 14971), Gage repeatability and reproducibility theory and application, statistics, project management (supporting multiple projects simultaneously), and reliability is preferred.
ASQ certification (CQE, CQM, CRE, CQA) is an asset. ASQ CSQE is preferred.
Experience with qualification of Commercial/Off-the-Shelf (COTS) and custom equipment is strongly preferred.
Experience with validation of COTS ((customer of the shelf) and custom software is preferred.
Six Sigma Green Belt, Black Belt, or Master Black Belt certification is an asset.
Knowledge of Regulatory compliance: GMP, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications is preferred.
Auditing skills such as - ISO, QSR (Quality Systems Regulations) and GMP standards is as asset.
This position will be located in Cincinnati, OH and will have up to 25% travel both domestically and internationally.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you? Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon Endo Surgery Inc (6041)