Principal Quality Engineer — Lead Quality Strategy & CI

Penumbra, Inc.; Roseville (CA); On-site; USD 135,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with company match

Paid parental leave

11 paid company holidays

Job summary

Penumbra, Inc. in Alameda, California, is seeking a Principal Quality Engineer to lead quality improvement across Operations.

You will apply analytical expertise to strengthen process capability, optimize inspection systems, and elevate quality performance through structured CI methodologies. Collaborating across Manufacturing Eng, Industrial Eng, Operations Leadership, and R&D, you will ensure quality by design, mitigate risks, and drive data‑driven improvements with rigor.

Qualifications

• Bachelor’s degree in Engineering; advanced degree preferred.
• 7+ years in Quality/ Manufacturing Engineering within medical devices.
• Experience with Lean and Six Sigma; leading large-scale CI.
• Expert understanding of FDA QSR and ISO 13485.
• Proven cross-functional leadership through complex challenges.
• Advanced data analysis and statistical modeling skills.

Responsibilities

• Lead cross-functional CI initiatives to reduce cost of poor quality.
• Identify quality improvements using data-driven methods.
• Own NCRs and CAPAs and participate in NCR boards.
• Develop CTQ flowdowns aligning product requirements and controls.
• Architect and optimize quality monitoring systems with predictive analytics.
• Lead complex problem solving using DOE, regression, multivariate analysis.
• Drive inspection systems, testing, and measurement capability.
• Champion Lean, Six Sigma, and operational excellence.
• Influence long-term quality strategy including digital quality.
• Train and mentor Quality Engineers.

Skills

Statistical analysis

Continuous improvement

Data-driven decision making

Lean Six Sigma

Cross-functional leadership

Quality engineering leadership

Education

Bachelor's in Engineering

Advanced degree preferred

Tools

Predictive analytics

Statistical process control

Data visualization tools

Job description

Penumbra, Inc. in Alameda, California, is seeking a Principal Quality Engineer to lead quality improvement across Operations.

You will apply analytical expertise to strengthen process capability, optimize inspection systems, and elevate quality performance through structured CI methodologies. Collaborating across Manufacturing Eng, Industrial Eng, Operations Leadership, and R&D, you will ensure quality by design, mitigate risks, and drive data‑driven improvements with rigor.