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Senior Quality Engineer
San Diego, CA US
Engineering & Architecture
Senior Quality Engineer
Job Summary Leads the development and launch of Class I and II Medical Devices. Supports organizational Quality/Business goals and objectives while providing team leadership support for process improvement. Primary Duties and Responsibilities * Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products. * Supports finished goods variance investigation and resolution, root cause analysis, and quality assurance testing methodology. * Represents Quality in planning, design, production process development and risk management on product development teams * Represents quality on design transfer teams. * Ensures process improvement activities remain in compliance with FDA/ ISO regulations/ standards/ guidelines and customer requirements. * Leads or participates in internal/external Quality System audits. * Reviews changes to products in production for reliability impact to aid in the correction process, design or material problems. * Ensures manufacturing process development activities are completed in a timely manner and in compliance with FDA standards and procedures and recommend actions or changes to improve quality. * Leads problem-solving efforts, including customer complaint investigation and analysis to identify and resolve sporadic and chronic quality issues to ensure production of safe and effective products. Required Experience:
Skills, Knowledge & Abilities * Excellent oral and written communication skills * Ability to motivate and maintain effective working relationships with staff and colleagues * Ability to work to in a fast-paced contract manufacturing environment * Effectively manages cost, quality and delivery objectives * Exemplary planning and communication skills * Advanced computer skills in Microsoft Office including Excel, Access, Word, PowerPoint, and Outlook. * Attention to detail * Persistent with follow-through * Facilitation and group problem-solving skills * Working knowledge of FDA QSR, ISO13485 and ISO14971 Education and/or Experience * 5-7 years experience in quality engineering * Theoretical knowledge typically achieved through a related four-year college experience, such as a Bachelor''s degree in engineering or the physical sciences. * Experience in Customer Focused Quality and/or Business Process Improvement Keyword: Senior Quality Engineer From: D&K Engineering