Senior Quality Engineer – Medical Device CSV & QA

Spectraforce Technologies, Inc.; Hayward (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Sr. Quality Engineer in Hayward, CA to support multiple product lines.

The role focuses on maintaining validation and risk management documentation, interacting with design and vigilance teams to address quality issues, and driving continuous improvement across manufacturing processes. The position encompasses equipment, process, or software validation within a GxP framework, requiring partnership with engineering to ensure a smooth transition of

Qualifications

• Bachelor's in Engineering with 3–5 years in Quality Engineering.
• Master's degree can substitute for 2 years of experience (Engineering or Business preferred).
• Lean or Six Sigma Green Belt or higher is preferred.

Responsibilities

• Evaluate operational data to generate proactive actions to reduce CIPM.
• Assure product compliance through inspection criteria in operations.
• Develop and analyze statistical data and product specifications for quality.
• Perform root cause investigations and document NCR/CAPA actions.
• Lead CSV and data integrity validation activities and support validation plans.

Skills

Quality Engineering

Process Validation

Risk Management

CSV/Data Integrity

Root Cause Analysis

GxP Compliance

Education

BA/BS in Engineering

Lean Six Sigma Green Belt or higher

Job description

Spectraforce Technologies, Inc. is seeking a Sr. Quality Engineer in Hayward, CA to support multiple product lines.

The role focuses on maintaining validation and risk management documentation, interacting with design and vigilance teams to address quality issues, and driving continuous improvement across manufacturing processes. The position encompasses equipment, process, or software validation within a GxP framework, requiring partnership with engineering to ensure a smooth transition of