Quality Engineer II, New Product Development & Life Cycle Management

Ethicon Surgical Care, a member of the Johnson & Johnson Family of Companies, is recruiting a Quality Engineer II, to be 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 Quality Engineer will function as a quality lead on cross-functional teams focusing on new product development and/or life cycle management projects.
This individual will support design control and process validation activities for new and change product efforts and will ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans and rationale.
This individual will lead the development of comprehensive risk documentation for the product and process and overall risk management plans and reports.
The Quality Engineer will be responsible for developing comprehensive quality strategies and will ensure the development and validation of appropriate test methods for the design and manufacture of products and components.
This individual will assist in thorough investigation of quality issues and implementation of effective corrective and/or preventive action(s). The 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.
This individual will also work on identifying areas of opportunity for improved customer experiences through the evaluation of available post-market customer data.
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 2 years of Quality Engineering work experience in FDA regulated industry for Medical Devices, Biologics, or Pharmaceuticals is required.
ASQ certification (CQE, CQM, CRE or CQA) preferred.
Knowledge of ISO and cGMP regulations is required.
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, Design Control, Risk Assessment and Process Validation is required.
Candidate must be able to communicate effectively at all levels within Quality as well as cross functionally across departments such as R&D, Operations, Purchasing, Marketing and Medical Affairs.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

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