Quality Engineer II - Codman - (Job Number: 0809452)

Quality Engineer II - Codman - (Job Number: 0809452) DescriptionCodman && Shurtleff, Inc. a division of DePuy, Inc, a member of Johnson && Johnson's Family of Companies, is recruiting for a Quality Engineer II, located in Raynham Ma. Codman && Shurtleff, Inc. a division of DePuy, Inc. - Develops and markets products under DePuy Orthopaedics, Inc., DePuy Spine, Inc., Codman && Shurtleff, Inc. and DePuy Mitek. Among these are products for reconstructing damaged or diseased joints; repairing and reconstructing traumatic skeletal injuries; facilitating the treatment of spinal disorders and deformity; surgical treatment of neurological and central nervous system disorders, and sports medicine devices for the treatment of soft tissue injuries. DePuy has three main locations: Warsaw IN, Raynham Ma and Leeds, UK. DePuy is one of the largest businesses within Johnson && Johnson. Codman && Shurtleff develops and markets a wide range of diagnostic and therapeutic products for the treatment of central nervous system disorders. Our focus is on Intractable Pain Management, Pediatric && Adult Hydrocephalus, and Neuro Critical Care. Our product line includes Drug Pumps, Cerebrospinal Fluid Shunts, Advanced Neuro-Monitoring, and Electrosurgical Systems. We also represent a premier line of surgical instruments for all specialties in the Operating Room. The qualified candidate for this hands-on position should excel in an environment that embraces change, intelligent risk-based decision-making, and flexibility. This individual should be willing to make a visible contribution and be able to work with minimal supervision. Working in a team setting, this individual's major responsibilities will be as follows: Support and lead product Design Control activities for new product development efforts. The candidate will strategize, lead, and conduct Process and Design Validation activities, including risk assessments and validation protocols. In addition the candidate will help develop inspection methodology and acceptance criteria for inspection sample plans. The candidate will support operations in the creation of travelers, routes, bills of material, print changes, and specifications for in-house manufacturing, as well as maintain and improve the Codman Quality System, including CAPA, NCR, auditing (internal, supplier, and third-party), and manufacturing operations. The candidate will lead investigations and support resolutions of NCRs, CAPAs, and audits, as well as work closely with suppliers in the qualification of new parts and components. The candidate will provide leadership in understanding of the regulations to other disciplines. This candidate must be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&&D, Regulatory, Manufacturing, and Marketing in order to provide quality input. This position will require a minimum BS degree in a technical discipline with a minimum of 3 years of related experience. A Master's degree is a plus. Strong quality engineering skills with a proven track record in process validation and failure mode effects and analysis are required. Knowledge of the QSR and ISO/EN quality requirements is also required. Excellent problem solving and decision making skills are also a requirement for this position. Candidates should possess interpersonal skills that foster conflict resolution as it relates to technical situations. A proven track record of implementing Quality System improvements to meet compliance and overall business goals is desired. Some travel is required (domestic and international). This position is located in Raynham, Ma. Apply Now