The Quality Engineer II is responsible for ensuring product quality, process compliance, and effective execution of Quality Management System (QMS) requirements throughout the product lifecycle. This role partners with Manufacturing, Engineering, R&D, Regulatory Affairs, Quality Control, and Supply Chain teams to investigate quality issues, execute CAPAs, support risk management activities, maintain regulatory compliance, and drive continuous improvement initiatives. The position requires strong analytical skills, root cause investigation experience, and knowledge of regulated manufacturing environments such as medical devices, biotechnology, diagnostics, or pharmaceuticals.
Job Responsibilities
Investigate nonconformances, deviations, and quality issues.
Lead CAPA activities and root cause investigations using tools such as 8D, Fishbone, and 5-Why.
Conduct risk assessments (DFMEA, PFMEA, ISO 14971).
Support New Product Introduction (NPI), design control, validation, and change control processes.
Analyze quality metrics and manufacturing data to identify trends and improvement opportunities.
Support complaint investigations, audits, and regulatory inspections.
Ensure compliance with FDA, GMP, ISO 13485, and QMS requirements.
Drive continuous improvement initiatives using Lean and Six Sigma methodologies.
Numbers & Facts
Location
Fremont, CA
Job Type
Temporary
Salary
$40 Per Hour
Qualifications
Bachelor's degree in Engineering, Chemistry, Biology, Biotechnology, Life Sciences, or a related technical field.
2-5 years of Quality Engineering or Quality Assurance experience in a regulated manufacturing environment.
Preferred Skills
CAPA, Deviations, Nonconformance Management
Root Cause Analysis (8D, Fishbone, 5-Why)
ISO 13485, FDA QMSR, GMP
Risk Management (FMEA, ISO 14971)
Validation & Qualification
Medical Device, IVD, Biotech, or Pharmaceutical experience
MasterControl, Oracle, or other eQMS systems
Lean, Six Sigma, CQE, or CQA certifications
Skills
QUALITY ENGINEER
Quality Assurance
CAPA
Deviation
Root Cause Analysis
8D
5 Why
Fishbone
ISO 13485
FDA
GMP
QMS
ISO 14971
DFMEA
PFMEA
MEDICAL DEVICE
IVD
BIOTECHNOLOGY
Pharmaceutical
validation
Change Control
NPI
master control
Lean
Six Sigma
CQE
CQA
Skills
Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
Continuous Improvementunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Process Improvementunmatched
Product Lifecycleunmatched
Quality Controlunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Regulationsunmatched
Research & Development (R&D)unmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Supply Chainunmatched
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