Sr. Quality Assurance Engineer

DJO Incorporated is a leading global provider of high-quality, orthopedic devices, with a broad range of products used for rehabilitation, pain management and physical therapy sold through DJO, Empi, and our Chattanooga Group business units. We are the largest non-surgical orthopedic rehabilitation device company in the United States and among the largest globally.

We also develop, manufacture and distribute a broad range of surgical reconstructive implant products through our DJO Surgical business unit. We believe that our strong brand names, comprehensive range of products, focus on quality, innovation, customer service, extensive distribution network, and our strong relationships with orthopedic and physical therapy professionals have contributed to our leading market positions.

DJO is a global provider of medical devices that provide solutions for musculoskeletal health, vascular health and pain management. We are currently seeking a Sr. Quality Assurance Engineer for our Vista, CA location. This position is responsible for providing Quality Assurance input and guidance for Manufacturing, Supply Chain Quality, and R&D activities. Responsible for supporting quality assurance and regulatory issues to assure compliance with FDA regulations, corporate directives, ISO 13485 standards and company strategies. Requirements:

Education/Experience - A bachelor’s degree in a related field and/or a combination of practical and educational experience in the medical device industry. Minimum of five years in this industry or related industry as a Sr. Quality Engineer. Experienced in the application and implementation of (GMP/QSR/ISO/MDD and Canadian Medical Device Regulations) a plus, with focus on process validations, product development supports a must. ASQC certification with active local membership is preferred.

As the Sr. QE for Surgical Implantable Joints, this QE must have significant experience in this area as well as in complex metal working, finishing processes with medical grade/aerospace grade metals and machining processes.

Experience with alternative Quality related tools (QFD, SPC, Risk Analysis, DOE, and TQM and Lean Mfg.) also a plus. Lean Six Sigma Black Belt is a strong plus. Specific

Skills/Knowledge: Familiar w/the requirements of the QSR and have the ability to interpret and implement specifications, test methods, reports and procedures. Ability of present information to management regarding quality related issues. Able to make decisions based on facts and test results. Knowledgeable w/excel, access and other databases and spreadsheets a plus. Significant experience in complex metal working, finishing processes with medical grade/aerospace grade metals and machining processes

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