Quality Engineering Manager — Medical Devices

Penumbrainc; Alameda (CA); On-site; USD 145,000 - 214,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life and AD&D insurance

401(k) with employer match

Paid parental leave

11 paid company holidays + vacation

Job summary

Penumbra, Inc. is seeking a Senior Quality Engineer to lead a team supporting medical device manufacturing. You will own quality performance, inspection strategy, and process control from early ramp to mature products.

You will collaborate across Production, Manufacturing Engineering, and Industrial Engineering to embed quality into processes and prevent defects. The role emphasizes data-driven monitoring, NCRs/CAPAs, and risk management, with a focus on yield, reliability, and compliant

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related).
• 5+ years in Quality or Manufacturing Engineering in medical devices.
• 1+ year of leadership experience.
• FDA QSR and ISO 13485 knowledge in manufacturing.

Responsibilities

• Lead Quality Engineering support for assigned product portfolios and production lines.
• Partner with Production, Manufacturing Engineering, and Industrial Engineering.
• Own manufacturing quality performance including yield, scrap, and throughput-related losses.
• Advance inspection strategies, sampling plans, and acceptance criteria.
• Drive continuous improvement of inspection systems, test methods, and data-driven monitoring.
• Apply Lean and Six Sigma to improve yield and reduce waste.
• Oversee quality system activities: NCRs, CAPAs, MRB, control chart investigations.

Skills

Leadership

Data analysis

Quality engineering

FDA QSR / ISO 13485

Statistical methods

Education

Bachelors in Engineering

Tools

PowerBI

Tableau

Job description

Penumbra, Inc. is seeking a Senior Quality Engineer to lead a team supporting medical device manufacturing. You will own quality performance, inspection strategy, and process control from early ramp to mature products.

You will collaborate across Production, Manufacturing Engineering, and Industrial Engineering to embed quality into processes and prevent defects. The role emphasizes data-driven monitoring, NCRs/CAPAs, and risk management, with a focus on yield, reliability, and compliant