- 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
- 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's 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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Sr. Quality Engineer - Pleasanton, United States - Katalyst Healthcares and Life Sciences
