Quality Engineer II - (Job Number: 0800692)

Quality Engineer II - (Job Number: 0800692) DescriptionDepuy, Inc., Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Engineer II, located in Rayham, MA. DePuy, Inc. develops and markets products under the DePuy Orthopedics, DePuy Spine, CODMAN and MITEK brands. DePuy Orthopedics 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 qualified candidate for this hands-on Quality Engineer position should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. The Quality Engineer will be working in a design team setting, this individual's major responsibilities will be to support design control activities for new product development efforts. Conduct and lead Process Validation activities. Conduct Process/Design Failure Mode Effects and Analysis. Develop inspection methodology and acceptance criteria for Inspection sample plans. Conduct Internal Audits of the Quality System. Conduct audits of new suppliers as part of the project teams. Provide leadership in the understanding of medical device regulations to other disciplines. This QA Engineer must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Purchasing, Manufacturing, and Marketing. Minimum of a B.S. in Mechanical Engineering or equivalent with 3-5 years of related experience. A Master's degree is a plus. Strong engineering skills with working knowledge of process validation and verification activities (IQ, OQ, PQ, PPQ) software validation are required. Risk analysis techniques including FMEA (Failure Modes and Effects Analysis) are required. Excellent problem solving and decision making skills are a must. Interpersonal skills that foster conflict resolution as it relates to technical situations are highly required. Blue print reading and interpretation including Geometric Dimensioning and Tolerancing (GD&T) are required. Working knowledge of QSR and ISO quality system requirements are a must. Working knowledge of Microsoft office products (Word, Excel, Access, and Project) are required. Excellent written and oral communication skills are highly desired. 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! Apply Now