Senior Quality Engineer - Medical Device

General Summary

Join us in making a difference with life-saving medical devices! As a Senior Quality Engineer, you will take the lead on impactful projects that ensure high-quality manufacturing of Class II / III interventional medical devices. You'll tackle complex challenges by analyzing data and collaborating with teams to establish effective quality actions and objectives.

Specific Duties and Responsibilities

• Support Commercial Operations and Manufacturing through various quality assurance activities including inspections (incoming, in-process, final), Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), engineering change orders, and equipment maintenance.
• Analyze failure and defect investigations for assigned manufacturing product lines.
• Participate in and drive Continuous Improvement initiatives.
• Engage in supplier quality activities such as Second Source Qualifications, Supplier Changes, and Supplier Corrective Action Requests (SCARs).
• Collaborate with internal engineering teams and suppliers to resolve quality-related issues.
• Assist in the creation and improvement of manufacturing documentation.
• Design and enhance test methods, testing equipment, and test method validations (TMVs).
• Recommend enhancements for specifications, acceptance criteria, and manufacturing documentation to elevate product quality and operational efficiency.
• Mentor junior Quality Engineers to support departmental functions and initiatives.
• Ensure compliance with the Quality Management System (QMS), applicable regulations, standards, and procedures.
• Perform other relevant tasks as assigned.

Position Qualifications

Minimum education and experience :

Additional qualifications :

Working Conditions

This position involves working in general office, laboratory, and cleanroom environments. The role requires some lifting and moving of up to 25 pounds. Regular standing, walking, sitting, and reaching are needed along with the ability to use a computer for extended periods. Among other vision requirements, the ability to read, see colors and maintain peripheral vision is critical.

The position is based in Alameda, CA, with a starting base salary ranging from $109,000 to $152,000 annually.

What We Offer

A collaborative environment where you can continuously learn and thrive, working towards revolutionary treatments for serious diseases. We provide a robust benefits package for eligible employees, including healthcare coverage, 401(k) with employer matching, stock purchase options, paid parental leave, generous vacation and sick time, and much more.

Penumbra, Inc. is headquartered in Alameda, California, and is focused on innovative healthcare therapies. Join our dedicated team and contribute to the development of groundbreaking products that fulfill significant medical needs in hospitals and healthcare facilities worldwide.

Penumbra Inc. is an equal opportunity employer, committed to a diverse workforce. Qualified applicants will receive consideration for employment regardless of race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military status, or any other characteristic protected by applicable laws.