Quality Engineer II

SGS Consulting
California

Job Responsibilities:

  • Provides Quality leadership to new product development teams in the areas of validation, design transfer, risk management and specification development.
  • Author master validation plans and reports.
  • Author and execute validation protocols and reports (Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning).
  • Review the quality, validation impact, and completeness of document change order requests and change controls (Equipment or Facilities).
  • Determine validation strategy based on acceptable risk-based approach.
  • Lead cross-functional team to write PFMEAs under limited supervision.
  • Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV).
  • Assist in maintaining validation records.
  • Support cross-functional teams during New Product Introduction (NPI) and Sustaining projects.
  • Review regulatory submissions and/or notifications under limited supervision.
  • Propose improvement projects with supporting data, flowcharts, etc.
  • Assist in developing/updating departmental procedures and other controlled documents.
  • Evaluate adequacy of specifications for new or modified process designs under limited supervision.
  • Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines.
  • Participate in process design reviews.
  • Assist QE in Material Review Board (MRB) and Production Response Team (PRT) meetings.
  • Participate in department process improvement’s goal(s).
  • Assist in development, maintenance, and reporting of department metrics.
  • Provides management with status updates on assigned responsibilities, goals and escalate issues in a timely fashion.

Skills:

  • Proficient in validation methods and evaluation criteria.
  • 2+ years of experience
  • Experience with process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications.
  • Experience with change control process and documentation requirements.
  • Experience with electronic document management systems.
  • Understanding statistics, SPC and acceptance sampling.
  • Experience with risk analysis and PFMEA.
  • Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971).
  • Working knowledge of 21 CFR Part 11.

Education/Experience:

  • Bachelor’s degree in science or engineering
Posted 2025-11-14

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