Senior Quality Engineer – Medical Devices & Compliance

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

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Parental leave

Company holidays

Vacation and sick time

Job summary

Penumbra, Inc. in Alameda, CA seeks a Senior Quality Engineer to lead QA activities across manufacturing and product development. The role requires ensuring design control, quality systems, and regulatory compliance align with company objectives.

You will drive qualification efforts, support FDA inspections, and develop quality standards while mentoring staff and advancing patient safety. A competitive package with benefits is offered.

Qualifications

• Bachelor’s degree in Engineering, Life Science, or related field with 5+ years in QA/ISO.
• Experience in a medical device or regulated industry environment.
• PFMEA, NCRs, Failure Investigations, and Change Control experience preferred.

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 engineering work including inspection, testing, and evaluation method development and validation.
• Support FDA inspections, ISO audits, and notified body audits.
• Prepare SOPs and documentation for inspection/testing procedures.
• Adhere to QMS and regulatory standards; manage staff performance and development.

Skills

Quality Assurance

ISO compliance

PFMEA

Auditing

Quality systems

Regulatory guidance

Education

Bachelor’s degree in Engineering or Life Science

Advanced degree preferred

Job description

Penumbra, Inc. in Alameda, CA seeks a Senior Quality Engineer to lead QA activities across manufacturing and product development. The role requires ensuring design control, quality systems, and regulatory compliance align with company objectives.

You will drive qualification efforts, support FDA inspections, and develop quality standards while mentoring staff and advancing patient safety. A competitive package with benefits is offered.