Johnson & Johnson Careers
Senior Quality Engineer
San Angelo, Texas
Requisition ID: 2490180921
Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer to be located in San Angelo, TX.
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.
You, the Senior Quality Engineer will work closely with business partners utilizing various Quality Engineering tools in the development and manufacture of new products as well the maintenance of current products, materials and processes. This individual will function as a quality representative on multi-functional product development teams in matters relating to Quality Engineering. Support design control and process validation activities for new and change product efforts. 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. Lead and ensure the development of comprehensive risk management plans and operating procedures for the product and process. You, the Quality Engineer will ensure effective and comprehensive quality strategies. Assist in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action. Track/trend quality issues over time and generate reports to management and across sites. Provide guidance to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations. Assess, implement and monitor process capability for continuous improvement. Leading cross-functional work teams and/or manage QA technicians to include direct daily supervision, performance appraisal, behavioral discipline, professional development and on the job training.
Responsibilities include but are not limited to:
- Provide technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems.
- Provide support to J&J process excellence initiatives including Six-sigma & lean thinking.
- Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations.
- Ensure compliance with company policies and procedures including with all environmental, safety and occupational health policies. (i.e., ISO14001 & OSHAS18001).
- A minimum of a bachelor’s degree in required. A technical concentration in Engineering, Life Science, Physical Science or a related field is preferred. An advanced degree is an asset.
- A minimum of 4 years of relevant experience is required. Experience in Quality Engineering is preferred. Experience in the medical device, pharmaceutical or other highly regulated industry also preferred.
- Knowledge of ISO and/or cGMP regulations is preferred. New product development experience is preferred.
- Supplier Quality Engineering experience is an asset. Sterilization process experience is an asset. General knowledge in Quality Systems Regulations (QSR) is an asset.
- An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset.
- Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
- This position may require up to 10% domestic travel and may require the ability to work some nights/ weekends/ holidays depending on business needs.
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 is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Texas-San Angelo
Ethicon Inc. (6045)