Senior Quality Engineer - Medical Devices QA Leader

Penumbrainc; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid parental leave

Eleven paid company holidays

Vacation accrual

Job summary

Penumbra, Inc. in Alameda, CA is seeking a Senior Quality Engineer to lead quality assurance activities across design, development, and manufacturing, ensuring compliance with FDA regulations and industry standards.

You will develop quality plans, conduct risk analysis, manage NCR/CAPA processes, and support inspections, with a focus on continuous improvement and effective collaboration with cross‑functional teams.

Qualifications

• Bachelor’s degree in Engineering, Life Science or related field required.
• 5+ years of QA experience in medical device or regulated industry environment.
• Experience with PFMEA, NCRs, Failure Investigations, and Change Control.
• Auditing, design review, sterilization, project management or product development experience desired.

Responsibilities

• Lead and participate in development and qualification activities for new and existing products.
• Coordinate quality efforts across design, development, and manufacturing.
• Perform design control and quality assurance activities.
• Analyze reports and returned products to recommend corrective and preventive actions.
• Participate in NCR/CAPA boards and assist in QA training.
• Support FDA inspections and notified body audits.

Skills

Quality Assurance

PFMEA

Change Control

NCR / CAPA

Project leadership

Education

Bachelor’s degree in Engineering, Life Science or related field

Job description

Penumbra, Inc. in Alameda, CA is seeking a Senior Quality Engineer to lead quality assurance activities across design, development, and manufacturing, ensuring compliance with FDA regulations and industry standards.

You will develop quality plans, conduct risk analysis, manage NCR/CAPA processes, and support inspections, with a focus on continuous improvement and effective collaboration with cross‑functional teams.