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Senior Quality Engineer

Company: Johnson & Johnson Family of Companies
Location: San Angelo
Posted on: February 3, 2020

Job Description:

SunIRef:Manu:title Senior Quality Engineer Johnson & Johnson Family of Companies 4,910 reviews - San Angelo, TX Johnson & Johnson Family of Companies 4,910 reviews Read what people are saying about working here. Ethicon is recruiting for a Senior Quality Engineer located in San Angelo, TX Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit The Quality Engineer will work closely with business partners within the supply chain 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. 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 development of sampling plans. This person will lead comprehensive risk management plans and operating procedures for the product and process. The Quality Engineer will ensure effective and comprehensive quality strategies. Will assist in detailed investigation of quality issues and coordinate implementation of effective corrective and/or preventive action. They will ensure the development and validation of appropriate test methods for design and manufacture of products and components. The Quality Engineer will track/trend quality issues over time and generate reports to management and across sites. This Quality Engineer will provide mentorship to project teams, suppliers and other disciplines to ensure compliance with company policies and procedures as well as medical device regulations. Will assess, implement and monitor process capability for continuous improvement. This Quality Engineer may be responsible for leading multi-functional work teams and/or managing QA technicians to include direct daily supervision, performance appraisal, behavioral discipline, professional development and on the job training. Key Responsibilities 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. Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001). Qualifications Qualifications Education: A minimum of a Bachelor's degree in Engineering, Life Science, Physical Science or a related field is required; an advanced degree is an asset. Five or more years Quality Engineering work experience is preferred, with experience in the medical device, pharmaceutical or other highly regulated industry also preferred. Experience and Skills: Required: Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation. Candidate must be able to communicate effectively at all levels within the Quality group, as well as across functions such as R & D, Operations, Purchasing, Marketing and Medical Affairs. Good communication and presentation skills will be needed. Maturity and ability to display a high level of integrity is required. Preferred: Knowledge of ISO and/or cGMP regulations. New product development experience. Supplier Quality Engineering experience. Sterilization process experience. General knowledge in Quality Systems Regulations (QSR). ASQ certification (CQE, CQM, CRE or CQA). Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification. Other: Must read, write and communicate proficiently in English. This position may require up to 10% travel. The ability to work some nights/ weekends/ holidays may be required. The noise level in the work environment is usually moderate. Associate is required to wear gowning as per established Quality Procedures. 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. Primary Location United States-Texas-San Angelo- Organization Ethicon Inc. (6045) Job Function Engineering Requisition ID Johnson & Johnson Family of Companies - Just posted report job - original job

Keywords: Johnson & Johnson Family of Companies, San Angelo , Senior Quality Engineer, Engineering , San Angelo, Texas

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