Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, located in Somerville, NJ.
Ethicon, Inc. develops and markets products for surgery, wound management and advanced wound care treatment. Products are marketed through three divisions: Ethicon Products for precise wound closure and tissue repair; Ethicon Women's Health & Urology for minimally invasive women's health procedures; and Johnson & Johnson Wound Management for hemostasis and advanced wound care.
The Senior Quality Engineer will work closely with R&D and Supplier Quality Management 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 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 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, with an Advanced degree is preferred. A minimum of 4+ years of Quality Engineering experience is required. Experience in the medical device, pharmaceutical or other highly regulated industry is required. New product development experience is required. Supplier quality engineering experience is a plus. Experience with the development of Electro-mechanical devices is an asset. Knowledge of IEC 60601-1 is preferred. Knowledge of ISO and/or cGMP regulations is required. Strong knowledge in Quality Systems Regulations (QSR) preferred. ASQ certifications (CQE, CQM, CRE or CQA) is preferred. Six Sigma Green Belt or Black Belt is desired. Knowledge in Statistics, Sampling Planning, Reliability, Computer System Validation and Process Validation is an asset. 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 may require up to 20% travel.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!
