Description: Here at SynCardia we have a very special mission: to give end-stage heart failure patients the priceless gift of more time. More time with their families and friends, more time outside the hospital enjoying life and more time to receive a heart transplant. As a Senior Quality Engineer you will support the maintenance of the Quality System in accordance with 21 CFR 820, 803, 806 and ISO 13485. This role also Supports preparation and maintenance of compliance to ISO 14971. By implementing quality methods throughout the organization, driving the use of quality tools in operations and product development, and assist in resolving major quality issues. Our Senior Quality Engineers also support activities concerned with development, application, and maintenance of Quality standards for manufacturing processes, materials, and products. Essential Duties and Responsibilities Ensure the Quality Systems is compliant with 21 CFR 520, 803, 806 and 13485. Promote awareness of the Quality System and provide training to individuals across the organization on quality management philosophies, tools, techniques and best practices. Provide training and direction, as required, to junior team members within the Quality department. Implement cost of quality concepts, including quality cost categories, data collection, reporting etc., for manufacturing. Conduct inspections of components and subassemblies as required and document compliance to approved specifications and procedures. Initiate and coordinate laboratory testing of raw materials, assemblies, finished goods and environmental conditions. Devise sampling procedures and design and develop forms and instructions for recording, evaluating, and reporting quality and reliability data. Schedule and conduct Quality system audits or material and services suppliers. Coordinate and oversee sterilization validation activities. Ensure systematic planning, and controlling of product and process quality in manufacturing: Processes for planning product and service development Material control Acceptance activities Measurement Systems Implement a validation program for new/changed materials, equipment, processes and components. Support a systematic program for quality problem solving and continuous improvement in manufacturing Implement and support quality improvement models Corrective and preventive action Overcoming barriers to quality improvement Quality System Support Complaint handling and investigation CAPA handling and investigation Guidance for completion of failure investigations Participation in external audits - develop responses to queries during and following the audit Risk Management Responsibility and Authority Affecting Quality Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System. Identify and record potential problems relating to the product, process and Quality System. Initiate, recommend or provide solutions through designated channels. Record and/or report all instances of customer feedback on product. Verify the implementation of solutions. Report verbally and in writing to the Quality Manager regarding the progress and results of projects. Requirements: Skills and abilities (required for the job) Excellent communication skills Excellent writing skills Strong organizational skills Detail oriented Problem Solving and Critical Thinking Skills Ability to handle multiple tasks simultaneously Comfortable working independently and as a part of a cross-functional team Exhibits self-reliance in managing personal workload and schedule of deliverables Education, experience and training (required for the job) ASQ Certified Quality Engineer and Six Sigma black belt preferred Bachelor's Degree in a related field and/or equivalent combination of education and experience. 6-10 years of experience in a regulated industry, medical device preferred At least 5 years' experience in a class II or III medical device company Note: An advanced degree in Engineering or Life Sciences accepted in lieu of professional experience. Thorough understanding of quality philosophies, principles, systems, methods, tools, standards, organizational and team dynamics; customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics. Thorough understanding of a quality system and its development, documentation and implementation with respect to domestic and international standards and requirements. Thorough understanding of the audit process, including types of audits, planning, preparation, execution, reporting results and follow-up. Ability to develop and implement quality programs, including tracking, analyzing, reporting and problem solving. Ability to plan, control and assure product and process quality in accordance with quality principles which include reviewing processes, material control, acceptance sampling, and measurement systems. Thorough knowledge of statistical analysis, reliability, maintainability and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting. Thorough understanding of problem solving and quality improvement tools and techniques, including management and planning tools, preventive and corrective actions, and how to overcome barriers to quality improvements. Ability to acquire and analyze manufacturing data using appropriate standard quantitative and statistical methods across a spectrum of business environments to facilitate process analysis and improvement.