Quality Assurance Engineer

2 weeks ago


Pleasanton, California, United States Katalyst Healthcares and Life Sciences Full time
Key Responsibilities:
  • Engage in design evaluations, Risk Management, and Validation & Verification documentation throughout the Product Development lifecycle as necessary.
  • Oversee Design Transfer processes for new product launches, ensuring readiness in quality and manufacturing operations. Facilitate and/or lead Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), both internally and externally.
  • Formulate Master Validation Plans, Quality Plans, and associated Reports.
  • Deliver quality-related inputs and/or specifications as required.
  • Concentrate on and apply appropriate engineering principles to address reliability challenges.
  • Lead and manage quality assurance and requirements throughout development stages and post-market activities, including Change Control.
  • Incorporate lessons learned from previous/new products into ongoing or new projects.
  • Identify and oversee Critical to Quality (CTQ) elements.
  • Comply with established Corporate Quality standards, relevant Regulatory Guidelines, methodologies, and procedures, while remaining open to identifying areas for enhancement.
  • Focus on optimizing processes for improved efficiency.
  • Manage Documentation Control.
Qualifications:
  • Bachelor's degree in engineering (mechanical, industrial, chemical, electrical) or a related technical field, or an advanced degree in other disciplines, or equivalent experience is preferred.
  • Proven expertise with a minimum of 8 years in quality engineering and/or operational roles, including at least 5 years in an electro-mechanical assembly and testing manufacturing environment.
  • Skilled in interpreting mechanical schematics and GD&T.
  • Medical Device Auditor certification is a plus.
  • Certified Six Sigma Black Belt, Green Belt, or Lean Master preferred, with a track record of addressing root causes in project solutions.
  • Experience in Supplier Development and Management.
  • Accountable for adhering to FDA's Quality System Regulation (QSR), ISO 13485, ISO 14971, and all other applicable international regulatory standards.
  • Experience in Design Control and/or Design Assurance.
  • Strong analytical capabilities.
  • Experience collaborating on cross-functional, cross-business, and cross-cultural initiatives.
  • Hands-on approach to problem-solving.
  • Proficient in office software, including Database management, MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
  • Willingness to travel up to 10%.


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