Company: Katalyst Healthcares & Life Sciences
Posted on: May 17, 2023
- Participate in design reviews, Risk Management, Validation &
Verification plans and reports during Product Development as
- 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
- Provide quality inputs and/or requirements as
- Focuses and determines proper engineering principles on
- Drive and own quality assurance and requirements during
development phases and post-market release, including Change
- Implement lessons learned in other/new products, respectively
new or running projects.
- Identify and manage Critical to Quality (CTQ's)
- Adhere to defined and communicated Corporate Quality
requirements, applicable Regulatory Standards, methods, and
procedures, with openness to identifying improvements.
- Focus on streamlining activities for increased
- 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
- 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
- Proficiency in reading and interpreting mechanical drawings and
- 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
- Design Control and/or Design Assurance experience
- Excellent analytical skills.
- Experience working in cross-functional, cross-business and
- Hands-on personality.
- Competent using office software including Database management,
MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
Keywords: Katalyst Healthcares & Life Sciences, Pleasanton , Quality Engineer, Engineering , Pleasanton, California
Didn't find what you're looking for? Search again!
Loading more jobs...