Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Systems Engineer that can be located in Somerville, NJ or Cincinnati, OH.
The Ethicon 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 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.
The Senior Quality System Engineer will ensure implementation and support of key elements of the Ethicon Quality Management system
Principal Duties and Responsibilities
• Supports the process for maintenance of Notified Body certificates and through partnership with the Ethicon Notified Body for updates and renewals of certificates
• Leads/supports significant Quality System projects effectively using a working knowledge of project management techniques (e.g. Job descriptions, Quality Agreements, etc.)
• Supports internal and external audit/inspections.
• Leads/supports Integration of new facilities/businesses into the Ethicon Quality Management System
• Provides guidance and direction throughout the organization, sites and functions, for quality system processes
• Supports the implementation of regulatory standards as well as internal JNJ standards
• Leads change for process standardization, simplification, efficiencies through the use of process excellence tools/methodologies
• A minimum of a Bachelor’s Degree is required a concentration in a Science related field or Engineering is preferred
• A minimum of 5 or more years of related medical device or other highly regulated industry experience is required.
Required Knowledge, skills, abilities and certification/licenses:
• Knowledge of ISO and QSR regulations, ISO 13485 is required.
• Influencing skills, organization, and communication skills are required.
• Prior work experience in an FDA regulated environment is preferred
• Prior experience working with notified body is preferred.
• Strong knowledge of statistical methods is preferred.
• Process Excellence (Six Sigma / Lean etc.) experience is preferred
• Expert level MS Office (Excel, Word, Outlook, Visio) skills are required (knowledge of VBA preferred).
• Strong conflict resolution skills, project management skills, analytical reasoning and the ability to work in a cross-cultural environment are required
• Superior oral and written communication skills are required
• Knowledge of project management techniques (e.g. Job descriptions, Quality Agreements, etc.)
• This position is located in Somerville, NJ or Cincinnati, OH and may require up to 10% of both international and domestic travel.
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LI NAPrimary Location
United States-New Jersey-SomervilleOther Locations
North America-United States-Ohio-CincinnatiOrganization
Ethicon Inc. (6045)Job Function