Senior Quality Validation Engineer
Confirmed live in the last 24 hours
San Bruno, CA, USA
Experience Level
  • Bachelor's level degree or higher in Science, Engineering, or Software discipline
  • 5-7 years of related work experience in Validation or Quality for FUE, CSV, Automation, or Medical Device
  • Experience working in an FDA-regulated industry
  • Knowledge of System Development Life Cycles (SDLC) preferably with automated manufacturing and computerized lab systems
  • Knowledge of Validation Life Cycles (VLC) and applied experience in FUE, CSV, Automation, QC systems
  • Understanding of risk-based validation and data integrity requirements to perform assessments or apply applicable testing strategies
  • Practical knowledge of 21 CFR Part 11 (electron records/electronic signature), 21 CFR Parts 210, 211, GAMP 5, 21 CFR Part 820 and ISO 13485
  • Experience in supporting manufacturing of medical devices desired
  • Must possess excellent organizational, clear verbal, and written communication skills
  • High level of attention to detail and compliance and ability to effectively support multiple high priority deliverables at once
  • Hands on approach, self-motivated with a passion for problem solving
  • Working within a team of Quality Validation Engineers to support Quality, Facilities, Operations, QC, IT, Software, Mechanical, and Systems Engineering
  • Support, review, and approve documentation associated with qualification planning, intended use, user requirements, hazard analysis, risk assessments, functional and design specifications, design reviews, design V&V packages, test protocols, 21 CFR Part 11 compliance assessments, requirements trace matrix, Master Validation Plan and qualification report
  • For validation strategies and testing, perform independent reviews and apply knowledge of design, development, and testing of software used in Cellares' Cell Shuttle during their entire system development life cycle, from the requirements gathering phase to the retirement phase
  • Develop, review, and or approve FUE and CSV protocols (IQ, OQ, PQ), coordinate execution of testing, and generation, review, and approval of validation reports
  • Ensure that cGMP and Change Control related FUE, CSV, and software systems are established, implemented, and maintained to ensure regulatory compliance, data integrity, and to optimize efficient and effective business processes
  • Act as an effective leader in supporting Software Quality Assurance (CSA) disciplines, decisions, and practices with coaching, and mentoring for Quality, Engineering, and other technical team personnel
  • Provide direction to project teams on software, CSV, and FUE quality implementation processes and interpretation of procedural compliance requirements
  • Review and approve changes to existing systems, ensuring changes are implemented in compliance with internal procedures and external standards
  • Review test results for Good Documentation Practices (GDP) compliance and ensure that all test discrepancies to acceptance criteria are adequately controlled, documented, and addressed
  • Ensure the best quality practices are employed by all departments so that software/firmware based systems are developed, qualified, and maintained in a manner which provides assurance that the system conforms to both internal and external requirements
  • Author Standard Operating Procedures (SOPs) as required
  • Lead FUE or CSV related investigations and deviations generated during and post validation activities
  • As required, support audits, non-conforming events and CAPAs
  • Establish and promote an environment that supports the Quality Policy, cGMP, Data Integrity, and Quality Systems

51-200 employees

Cell therapy solutions