Quality Engineer II
Job in
Sacramento, Sacramento County, California, 95828, USA
Listed on 2026-10-18
Listing for:
SGS Consulting
Full Time
position Listed on 2026-10-18
Job specializations:
-
Engineering
Quality Engineering, Process Engineer, Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
- 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 escape issues in a timely fashion.
- 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.
- Bachelor’s degree in science or engineering
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