HireDiversity

Somerville, NJ, US

Staff Quality Engineer, New Product Development-8165121025

Description

Ethicon Surgical Care, a member of the Johnson & Johnson Family of Companies, is recruiting a Staff Quality Engineer, to be located in Somerville, NJ.

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.

The Staff Quality Engineer will work closely with R&D and Operations utilizing various Quality Engineering tools in the development and manufacture of innovative new products as well the maintenance of current products, materials and processes. This individual will function as a quality lead on multi-functional product development teams in matters relating to Quality Engineering. Will support design control and process validation activities for new and change product efforts. This individual will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sample plans. This individual will lead and ensure the development of comprehensive risk management plans for the product and process. The Staff Quality Engineer will ensure effective and comprehensive quality strategies. Will ensure the development and validation of appropriate test methods for design and manufacture of products and components. Will assist in thorough investigation of quality issues and effective corrective and/or preventive action. This Staff Quality Engineer will provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations.

Qualifications


A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required; an advanced degree is preferred. A minimum of 7 years of Quality Engineering work experience in a highly regulated industry is required, Medical Device experience highly preferred. ASQ certification (CQE, CQM, CRE or CQA) preferred. Knowledge of ISO and cGMP regulations is required. New product development experience is required. Supplier Quality Engineering experience is an asset. Strong knowledge in Quality Systems Regulations (QSR) preferred. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is highly desired. Intermediate to advanced knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is required. Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Purchasing, Marketing and Medical Affairs. This position will require up to 15% domestic and international travel.

BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-New Jersey-Somerville
Organization: Ethicon Inc. (6045)
Relocation: Eligible
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