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JOB REQUIREMENTS: Give hope. Give health. Make your mark in the fight against cancer. At Accuray, we make a direct and powerful impact on the lives of cancer patients every day - helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer - helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world. Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makestreatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives. Job Description SUMMARY: The Quality Engineer will represent Quality Assurance on product and process development teams and participate in development, review, and approval of Product Quality. Manufacturing project plans, and process assignments may be used for development or production support on an individual basis. Ensures Quality Assurance oversight for Stocking, Packaging and Logistics activities. REPORTING TO/DEPARTMENT: Reports to the Manager, Quality Assurance in the Manufacturing Quality department. ESSENTIAL DUTIES AND RESPONSIBILITIES: Manage and Maintain Quality Assurance, and Compliance activities throughout Manufacturing operations (at Madison Locations). Ensure compliance and continued certification to ISO 13485 Quality Systems Standard. Maintain a culture of Quality as it pertains to Accuray products and services. Engage with Product Development Teams to remain aware of PDT status. Review Engineering changes and attend Design Reviews to ensure clarity and adequacy of product quality attributes. Use of quality analytics to monitor and evaluate quality through Material Review Boards (MRB\'s) and Production and Process Control Evaluation (P&PC). Provide Process Validation (PV) guidance for Manufacturing Engineers. Review and approve PV protocols (EQ, IQ, OQ, PQ). Provide guidance for proper use of NCMR, Rework, Engineering Study and Deviation processes. Active Management of Product Hold process. Perform periodic/scheduled GEMBA walks to maintain adherence to 5S/6S. Monitor and report manufacturing quality performance metrics and trends. Support Internal and External Audit programs as required. Contribute to development of SCOPQ, cost of quality metrics and back-charge program. Champion improvement activities in conjunction with internal stakeholders. REQUIRED QUALIFICATIONS: Preferred or Desired: Fundamental knowledge of ISO 9001 or ISO 13485, and Medical Device Regulations. Working knowledge of SPC, Process Capability, Sampling Plans, Validation, and similar... For full info follow application link. We are an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans and individuals with disabilities are encouraged to apply. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/0B532520A46A4A27