Senior Quality Engineer - Medical Devices & Regulatory

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

AD&D

Disability insurance

401(k) with employer match

Parental leave

Paid vacation

Paid holidays

Paid sick time

Job summary

Penumbra, Inc. is seeking a Sr. Quality Engineer to lead quality assurance activities across manufacturing and product development in California.

You will plan, implement, and refine quality standards, assist with regulatory compliance, and support FDA inspections while guiding design controls. The role emphasizes independent evaluation, development of QA procedures, and collaboration with cross-functional teams to ensure product quality and regulatory adherence.

Qualifications

• Bachelor’s degree in Engineering or Life Science with 5+ years in QA/ISO environments.
• Advanced degree preferred.
• Experience in auditing, design review, sterilization, and project management.
• Experience with electronic devices and PCBAs.
• Experience with contract-manufactured electromechanical medical devices.

Responsibilities

• Participate in development and qualification activities for new and existing products.
• Lead project teams coordinating quality efforts to design, develop, and continuously improve products.
• Maintain and track hardware PCB issues and communicate with stakeholders.
• Perform engineering work with design controls and regulatory standards compliance.
• Analyze reports and returned products; recommend CAPA.
• Participate in NCR or CAPA boards as necessary.
• Assist in QSR training.
• Support FDA and notified body inspections.
• Develop standard operating procedures.
• Adhere to QMS and company procedures.
• Select, manage, train staff; provide performance feedback.

Skills

Auditing

Design review

Project management

Sterilization

Electronic hardware

PCBAs

Education

Bachelor’s degree in Engineering or Life Science

Advanced degree

Job description

Penumbra, Inc. is seeking a Sr. Quality Engineer to lead quality assurance activities across manufacturing and product development in California.

You will plan, implement, and refine quality standards, assist with regulatory compliance, and support FDA inspections while guiding design controls. The role emphasizes independent evaluation, development of QA procedures, and collaboration with cross-functional teams to ensure product quality and regulatory adherence.