Quality Systems Engineer - Process Improvement & Audits

GCM Medical and OEM, Inc.; San Jose (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

GCM Medical and OEM, Inc. is seeking a Quality Engineer to analyze trends, drive process improvements, and lead major quality initiatives in our manufacturing environment in San Jose, CA.

The role emphasizes coordinating corrective actions, performing root-cause analyses, and ensuring compliance with quality systems. Candidates should have 3–6 years of QA experience and an Associate or Bachelor’s degree in a technical field.

Qualifications

• Associate or bachelor’s degree in a technical field or related discipline.
• Relevant experience in Quality Assurance within manufacturing or medical device environments.
• Lean Six Sigma knowledge or certification is a plus.

Responsibilities

• Coordinates with customers on quality concerns and leads improvement projects.
• Leads corrective actions using 8D, 5-Why and fishbone analysis.
• Analyzes system data to identify major contributors to poor performing processes.
• Proactively identifies potential failure modes and recommends preventive actions.
• Evaluates project performance during and after completion.
• Leads cross-functional teams to develop and improve systems and processes.
• Creates PFMEA, MSA, Control Plan and capability studies for deliverables.
• Compiles PPAPs, defect containment, and root cause analyses.
• Analyzes production and supplier nonconformance data to determine root causes.
• Reviews customer returns to determine underlying issues.
• Improves QMS documents, procedures, forms and work instructions.
• Collaborates with suppliers, engineering, maintenance, purchasing, and operations to resolve issues.
• Leads supplier surveillance and on-site assessments of materials and processes.
• Issues, tracks, verifies root cause solutions, and closes corrective actions.

Skills

Quality Assurance

Process Improvement

Data Analysis

Cross-functional Collaboration

Education

Associate degree

Bachelor’s degree

Tools

PFMEA

MSA

Control Plan

Capability Studies

8D Problem Solving

Job description

GCM Medical and OEM, Inc. is seeking a Quality Engineer to analyze trends, drive process improvements, and lead major quality initiatives in our manufacturing environment in San Jose, CA.

The role emphasizes coordinating corrective actions, performing root-cause analyses, and ensuring compliance with quality systems. Candidates should have 3–6 years of QA experience and an Associate or Bachelor’s degree in a technical field.