Senior Quality Engineer - Medical Devices QA Lead

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

Benefits offered by this job

Medical, dental, vision insurance

Life and disability insurance

401(k) with employer match

Paid parental leave

Paid vacation and holidays

Paid sick time

Job summary

Penumbra, Inc. is seeking a Senior Quality Engineer in Alameda, CA to drive quality systems across product life cycles. You will lead design control activities, qualification programs, and supplier/product audits while ensuring compliance with regulatory standards.

The role involves conducting CAPA/NCR processes, developing measurement methods, and supporting FDA/Notified Body inspections, with opportunities to influence QA strategy and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering, Life Science or related field with 5+ years QA/ISO experience in medical devices or regulated industry.
• Experience with quality systems, regulatory compliance, and FDA/Notified Body inspections is preferred.
• Experience in auditing, design reviews, sterilization, project management, and product development highly desired.

Responsibilities

• Participate in development and qualification activities for new and existing products.
• Lead and participate in project teams coordinating quality efforts to design, develop, and improve products.
• Perform design control activities and ensure product meets guidelines and regulatory standards.
• Develop and validate measurement methods and inspection procedures.
• Support QMS, CAPA/NCR processes, and FDA inspections as needed.
• Prepare documentation for inspection/testing procedures and ensure training.

Skills

Quality Assurance

Project management

Auditing

Design review

Product development

Education

Bachelor’s degree in Engineering or Life Science

Advanced degree preferred

Tools

PFMEA

Change Control

NCRs / CAPA processes

Job description

Penumbra, Inc. is seeking a Senior Quality Engineer in Alameda, CA to drive quality systems across product life cycles. You will lead design control activities, qualification programs, and supplier/product audits while ensuring compliance with regulatory standards.

The role involves conducting CAPA/NCR processes, developing measurement methods, and supporting FDA/Notified Body inspections, with opportunities to influence QA strategy and continuous improvement.