QA Engineer Principal Monday to Friday 7:00am to 4:00pm

Profile

Essential Functions: Provides daily support to production through active involvement and presence in the assembly operations and clean rooms. Maintains and supports compliance activities associated with the Quality Management System (QMS) to comply with international and domestic regulations. Maintains the Corrective and Preventative Actions (CAPA) system and files. Coordinates CAPA activities including investigations, root cause analysis, and implementation of corrective actions with effectivity analysis. Develops quality assurance specifications, test devices and methods, inspection procedures, sampling plans, and related written procedures. Supports new product launch, risk management activities - failure mode, effects & criticality analysis (FMECA), master validation plans, product verification and validation (V&V), process validations, and design transfer into manufacturing. Implements and reviews changes to existing products, procedures, standard operating procedures (SOP), test methods, process changes, design changes, labeling/labels, and field issues to define the requirements for regulatory submissions and notifications. Supports internal audit process and follows-up on audit findings. Supports and develops quality metrics. Monitors production/product non-conformance trends in order to alert senior management of these trends so corrective actions can be implemented. Recommends modifications to existing quality or production standards to achieve optimum quality and compliance. Provides quality engineering support to quality control. Provides guidelines on inspection methods and equipment used, including measuring systems capabilities. Works with Manufacturing and Engineering teams to coordinate pilot production of new process validations and risk analysis activities. Conducts investigations of nonconformance reports (NCR) and complaints. Provides corrective and preventive actions based on sound engineering analysis and review. Provides effective solutions that will drive continuous and measurable improvements. Teaches quality engineering tools within the organization including risk management assessments using ISO 14971. Ensures calibration and preventive management systems meet compliance requirements. Identifies and ensures the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identifies opportunities for re-design/design of complex equipment, tools, fixtures, etc. to improve manufacturing processes and reduce risk. Provides guidance and oversight to multiple teams working on numerous products or developing various forms of technologies. Conducts engineering studies and investigations. Prepares reports for company leadership. Provides engineering guidance to other departments, helps to train new engineers, and keeps abreast of industry trends and issues. Serves as a technical expert to improve awareness, visibility, and communication on quality initiatives to support departmental and corporate quality goals and priorities. Performs other related duties and projects as business needs require at direction of managementEducation and Experience:Bacheloru2019s degree in Science or a related field; or an equivalent combination of experience and training; advanced degree preferred.Minimum twelve (12) years of experience in quality engineering and risk management, or any equivalent education and/or experience from which comparable knowledge, skills and abilities have been demonstrated/achieved.Previous project management experience.Special Requirements/Certification:ASQ CQE or other certifications preferredu00A0Knowledge, Skills, and Abilities:Ability to identify, interpret, and apply ANSI/ASQ Z1.4 and Z1.9 standards for attributes and variables sampling. Ability to identify and distinguish between single, double, multiple, sequential, and continuous sampling methods. Knowledge in selecting and describing appropriate uses of inspection tools.Ability to interpret the concepts of producer and consumer risk and related terms, including operating characteristics (OC) curves, acceptable quality limit (AQL), and lot tolerance percent defective (LTPD).Knowledge of and adherence to Quality systems.Proficient knowledge of general office procedures.Knowledge and understanding of policies, procedures, and guidelines relevant to quality compliance.Proven expertise in MS Office Suite (Excel, Word, Outlook, and PowerPoint).Demonstrated problem-solving, critical thinking, and investigate skills.Demonstrated attention to detail and accuracy.Ability to manage confidential information with discretion.Ability to interact professionally with all organizational levels.Ability to manage competing priorities in a fast-paced environment.Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.Ability to contribute effectively as a member of a team and work cohesively as a part of a team.Ability to effectively prioritize duties and efficiently complete responsibilities.Ability to maintain punctual attendance, including the ability to work outside of scheduled work shift when necessary.Pay: $103,255.88 - $172,093.13

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