Senior Development Quality Engineer - Medical Devices

Penumbra, Inc.; Alameda (CA); On-site; USD 125,000 - 175,000; Full time

Benefits offered by this job

Medical benefits

401(k) match

Parental leave

Paid holidays

Vacation accrual

Job summary

Penumbra, Inc. in Alameda, CA, is seeking a Senior Development Quality Engineer to lead Quality Engineering within a product development team, design and qualify new life-saving devices, implement design control, and ensure QMS compliance.

You will drive audits, support FDA inspections, and collaborate across functions to maintain high standards, focusing on accuracy, problem solving, and regulatory readiness.

Qualifications

• Bachelor’s degree in engineering with 5+ years in QA for medical devices.
• Experience with ISO and FDA inspections is preferred.
• Proficiency in statistics and quality tools.

Responsibilities

• Lead development and qualification activities for new and existing products.
• Coordinate quality efforts across teams to design and improve products.
• Develop and validate inspection and testing procedures.
• Support FDA inspections and audits.
• Ensure compliance with QMS and design control requirements.
• Perform data analysis to determine root causes and CAPAs.

Skills

Quality Engineering

Regulatory compliance

Auditing

Design control

Statistical analysis

Quality System

Education

Bachelor’s degree in Engineering

Tools

MS Word

Excel

PowerPoint

Job description

Penumbra, Inc. in Alameda, CA, is seeking a Senior Development Quality Engineer to lead Quality Engineering within a product development team, design and qualify new life-saving devices, implement design control, and ensure QMS compliance.

You will drive audits, support FDA inspections, and collaborate across functions to maintain high standards, focusing on accuracy, problem solving, and regulatory readiness.