Quality Engineer

1 month ago

Pleasanton, United States Katalyst Healthcares and Life Sciences Full time

Responsibilities: Should be able to handle stress and pressure at times 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment. Team player Design Control and/or Design Assurance experience Risk management Supplier Development and Management experience. change control Risk management exp Development of Master Validation Plan, Quality Plans and Reports GMP Background in medical device products Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness. Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally. ISO 13485, ISO 14971 Design history files, master record Design transfer process Documentation control Design history file / design master record Coordinate team in variosu projects Pharma or aerospace or medical device industry exp will work Should be able to work in fast paced environment 15 yrs of exp will also work Design Control and/or Design Assurance experience Supplier management Documentation control Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required. Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness. Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally. Development of Master Validation Plan, Quality Plans and Reports Provide quality inputs and/or requirements as applicable. Focuses and determines proper engineering principles on reliability issues. Drive and own quality assurance and requirements during development phases and post-market release, including Change Control Implement lessons learned in other/new products, respectively new or running projects. Identify and manage Critical to Quality (CTQ's) dhere to defined and communicated Corporate Quality requirements, applicable Regulatory Standards, methods, and procedures, with openness to identifying improvements. Focus on streamlining activities for increased efficiencies. Control of Documentations Requirements: Bachelor's degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred. Demonstrated competency with desired 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment. Proficiency in reading and interpreting mechanical drawings and GD&T. Medical Device Auditor certification preferred. Certified Six Sigma Black Belt, Green Belt or Lean Master preferred with proven completion of projects in which solutions were sought at the root level of the problem. Supplier Development and Management experience. Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO 13485, ISO 14971, and all other international regulatory requirements with which client complies. Design Control and/or Design Assurance experience Excellent analytical skills. Experience working in cross-functional, cross-business and cross-cultural projects. Hands-on personality. Competent using office software including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook. 10% Travel

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