Senior Quality Engineer
Employer: Auris Health, Inc.
Job Title: Senior Quality Engineer
Job Code: A011.3897
Job Location: Santa Clara, CA
Job Type: Full-Time
Rate of Pay:$102,000 - $125,000/year
Job Duties: Provide quality industrial engineering support for manufacturing. Develop, modify, apply, and maintain quality standards and protocol for processing materials into partially finished or finished materials projects. Collaborate with engineering and manufacturing functions to ensure quality standards are in place. Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Design or specify inspection and testing mechanisms and equipment utilizing the knowledge of industrial engineering theories. Review the production schedules, engineering specifications, process flows, and other information to understand the methods that take place in manufacturing services. Conduct quality assurance tests. Perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements while implementing quality control procedures to resolve production problems or minimize costs. Apply knowledge of industrial engineering principles of calculus and other advanced mathematics for analysis in the areas of design, incoming material, production control, production evaluation and reliability, inventory control, and research and development as they apply to product or process quality. Utilize the knowledge of statistical methodologies, as appropriate, for conformity assessment and investigative activities to resolve potential product and quality system opportunities for improvement. Review equipment and process validations, changes, nonconformances, etc., in order to ensure compliance and assess the impact on product reliability, process capability, and compliance status. Review and approve test method validation and stability plans and reports. Lead and/or participate in corrective/preventative action teams in resolving production, customer, and supplier issues (e.g. nonconformances, CAPA or CAPA activities, audit findings, complaint investigations, etc.). Lead process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design as well as designing control systems to coordinate activities and production planning in order to ensure that products meet quality standards. Develop product quality plans, documents, and systems by creating product specifications, quality specifications, and quality plans in conjunction with other product development team members as well as creating risk analyses and FMEAs.