Quality Engineer III - (Job Number: 0801110)

Quality Engineer III - (Job Number: 0801110) DescriptionDePuy, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer III in Miami, Florida. DePuy, Inc. develops and markets products under the DePuy Orthopaedics, DePuy Spine, CODMAN and MITEK brands. DePuy Orthopaedics and DePuy Trauma and Extremities provide products for reconstructing damaged or diseased joints, and for repairing and reconstructing traumatic skeletal injuries. DePuy Spine facilitates fusion of the spine and correction of spinal deformities, including CHARIT, the first artificial spinal disc. Codman provides for the surgical treatment of neurological and central nervous system disorders through products such as hydrocephalic shunt valve systems, implantable drug pumps and micro-surgical instrumentation. DePuy Mitek offers innovative devices in sports medicine for the treatment of soft tissue injuries. The Quality Engineer III will develop, implement and maintain quality systems and provide technical contribution in a team environment. May specialize in areas supporting product development, in-house production, or supplier management as they apply to quality systems or may otherwise specialize in one or more specific product group(s)/processes. Perform all job duties in full accordance with the worldwide policies on Information Asset Protection, maintain password(s) as confidential, and protect critical business information. Incumbent knows, understands, incorporates and complies with all applicable laws and regulations relating to DePuy's business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. Participates in design and process risk analysis (FMEAs), develops and executes design and manufacturing process validations/verifications and determines appropriate sampling plans for subsequent routine production. Will devise and implement methods and procedures for inspecting, testing and evaluating production. Provides technical Quality support to assigned inspection and manufacturing area(s). Develops solutions to problems of moderate scope and complexity. Erroneous decisions or recommendations or failure to achieve results might cause significant delays to program schedules and may result in negative financial implications. Contributes to the functional milestones associated with specific projects. May monitor and analyze supplier and/or internal performance and nonconforming product data to identify products or processes requiring quality improvements. Determines and implements the appropriate corrective actions. Performs internal and/or supplier audits (Supplier Management). Participates in pre-production activities for new and transferred products. Investigates internal and external system failures and ensures successful resolution. Maintains systems' inspection readiness. Participates in the training and mentoring of new and lower level Quality Engineers. Resolves difficult technical issues; prioritizes work to meet deadlines. Suggests and implements tactical direction for functional area. Researches and benchmarks creative solutions. Develops the basic work assignments and tactical plans to get the work done, and/or, contributes expertise to programs and projects. High-level technical contributor on teams and may serve in a project leadership role. Develops, implements and conducts training in Quality Systems procedures to enhance efficiency and compliance (i.e Product/Component Disposition, Non Conformance System, Corrective & Preventive Action System (CAPA), and Device History Records/Retention). In lieu of a Bachelor's Degree, a minimum of 10 years quality experience within an FDA regulated environment is required; preferably medical device. Candidates will preferably have a Bachelors Degree along with 4 years of the same experience. Any Process Excellence and/or ASQ certifications would be a plus. Prior auditing experience would be an asset. Must have had prior project management/leadership experience. Statistical process control experience is required. Must be proficient with Microsoft Office products including Power Point, Excel and Word. Prior regulatory compliance experience would be a plus. Geometric dimensioning and tolerancing experience is required. Must have excellent communication, multi-tasking and collaborative skills. The ability to work under little supervision and influence others in a matrix environment is required. This position requires up to 25% travel; mainly national. Apply Now