Senior Engineer, IC Quality

Senior Engineer, IC Quality. Cirtec Medical Corporation seeks a Senior Engineer, IC Quality in Chandler, Arizona. Develop, establish, and maintain quality engineering methodologies, systems and practices which meet customer and regulatory requirements. Focus on providing quality engineering support to the new product development process, operations/production, and quality systems. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support site and corporate quality goals and priorities. Provide Quality Engineering support for engineering product development and sustained fabless manufacturing of integrated circuits (ICs). Ensure quality requirements are communicated and met at IC suppliers (wafer fab, assembly, and test houses). Review supplier records and test data report to perform lot release activity for ICs, including COC issuance. Provide Quality Project Management support as needed for product transfers from development to validation to production. Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination. Develop and maintain Standard Operating Procedures. Develop and maintain project Quality Plans for assigned projects. Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement. Lead the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols, and equipment calibration/maintenance to ensure compliance with the Quality System. CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the corrective action system and procedures. Interact with customers and suppliers to resolve CAPA and complaint investigations. Provide Quality Support for the disposition of material via NCRs. Support supplier quality activities including supplier approval and maintaining and assessing supplier performance data (i.e. SCAR/on time). Provide audit support for third party audits, customer audits and internal audits. Support the implementation of continuous improvement initiatives. Develop and maintain supplier control plans. Initiate and maintain SPC (Statistical Process Control) for production processes Lead FMEA (Failure Modes & Effects Analysis) and DOE (Design of Experiment) as applicable. Other duties as assigned. Must have proof of legal authority to work in the U.S. Requirements - Education: Master's degree (U.S. or foreign equivalent) in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering or a closely related field. OR Bachelor's degree (U.S. or foreign equivalent) in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering or a closely related field. Experience: - For candidates with a qualifying Master's degree - three years of experience in a Manufacturing Engineer, Quality Engineer, Senior Quality Engineer, R&D Design Engineer, or similarly titled role in manufacturing in the medical device environment implementing quality programs or following quality programs, or in manufacturing in the integrated circuits or semiconductors environment implementing quality programs or following quality programs, as well as three years of experience implementing process improvement, or continuous improvement, methodologies in a medical device manufacturing environment or manufacturer of integrated circuits or semiconductors. All experience may be gained concurrently in the same three-year period. For candidates with a qualifying Bachelor's degree - five years of experience in a Manufacturing Engineer, Quality Engineer, Senior Quality Engineer, R&D Design Engineer, or similarly titled role in manufacturing in the medical device environment implementing quality programs or following quality programs, or in manufacturing in the integrated circuits or semiconductors environment implementing quality programs or following quality programs, as well as five years of experience implementing process improvement, or continuous improvement, methodologies in a medical device manufacturing environment or manufacturer of integrated circuits or semiconductors. All experience may be gained concurrently in the same five-year period. Infrequent travel to U.S. and foreign supplier locations, less than 5% of the time. The salary for this position has a range of $125,840 to $138,500 with standard employee benefits. Interested candidates should apply online at www.cirtecmed.com/careers. This position is for full-time employment by Cirtec Medical Corporation for employment in Chandler, Arizona. EOE.