Principal Quality Engineer - (Job Number: 0804557)

Principal Quality Engineer - (Job Number: 0804557) DescriptionCordis Corporation, a Member of Johnson & Johnson's Family of Companies is recruiting for a Principal Quality Engineer, located in Miami, Fl or Warren, NJ. The Principal Quality Engineer will be responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products. Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products. Analyzes reports and returned products and recommends corrective action. Prepares documentation for inspection/testing procedures. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Has full technical responsibility for interpreting, organizing, executing, and coordinating assignments. Plans and develops engineering projects concerned with unique or controversial problems which have an important effect on major organization programs. This involves exploration of subject area, definition of scope and selection of problems for investigation and development of novel concepts and approaches. As individual technical expert, conceives or is assigned, plans, and conducts research in problem areas of considerable scope and complexity. The problems must be approached through a series of complete and conceptually related studies, are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques. Available guides and precedent contain critical gaps, are only partially related to the problem or may be largely due to the novel character of the project. At this level, the individual researcher generally will have contributed inventions, new designs, or techniques, which are of material significance in the solution of important problems. As a staff specialist, serves as the technical expert for the organization (worldwide) in the application of advanced theories, concepts, principles, and processes for an assigned area of responsibility (i.e., subject matter, function, type of facility, or equipment, or product). Keeps abreast of new methods and developments affecting his/her organization for the purpose of recommending changes in emphasis of programs or new programs warranted by such development. Evaluates progress and results obtained, and recommends major changes to achieve overall objectives. Or, as individual technical expert may technically supervise other engineers or technicians on particular projects, which may be related to current major projects. Practices company health, safety and quality policies and procedures; actively requires conformance. Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company. Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. Major responsibilities include: Conduct and lead process and product validation and verification activities. Conduct or support failure and complaint investigations. Initiate and support continuous process improvements with in area of responsibility. Conduct supplier quality system and product audits. Define controls to meet product/process requirements. BA in an applicable engineering discipline; and 14 or more years of related experience and/or training; or Master's degree in an applicable engineering discipline plus 12 or more years of related experience and/or training; or Ph.D. in an applicable engineering discipline and 9 or more years of related experience and/or training; or equivalent combination of education and experience is required. Experience in the medical device industry is required. Validation & Verification experience is preferred. A CQA certification is preferred. Travel of up to 20% is required. Strong engineering skills with working knowledge of: Process validation and verification activities. Risk analysis techniques including FMEA (Failure Modes and Effects Analysis) and problem solving techniques including root cause analysis and cause and effect analysis is required. Knowledge of Statistical techniques and methods are required. Blue print reading and interpretation including Geometric Dimensioning and Tolerancing (GD&T) are preferred. Working knowledge of QSR and ISO9001/EN46001 quality system requirements are required. Working knowledge of Microsoft office products (Word, Excel, Access, and Project) is preferred. Excellent written and oral communication skills are required. The qualified candidate for this hands-on position should be able to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision. The individual must be capable of working independently and in a team setting. Apply Now