Supplier Quality Engineer II

Penumbra • Alameda, CA

1d • $90,000 - $121,000 • Onsite

About The Position

As a Supplier Quality Engineer II at Penumbra, you will play a key role in ensuring our supply chain consistently delivers components and materials that meet the highest standards of quality and compliance. Working closely with cross-functional partners in Operations, Compliance, and R&D, you will drive supplier qualifications, changes, corrective actions, and performance monitoring. You’ll help resolve supplier-related issues, drive improvements, and ensure adherence to Penumbra’s Quality Management System (QMS) and regulatory requirements.
This is an excellent opportunity to play a key role within a high-impact quality organization by driving supplier quality activities. You’ll join a collaborative and growing team that invests in technical development and career growth.

Requirements

• Bachelor’s degree in engineering, science, or a related field.
• 3+ years of experience in engineering, preferably in a medical device environment, an equivalent combination of education and experience, and/or demonstrated performance.
• Demonstrated experience in Supplier Quality Engineering, Supplier Engineering, Manufacturing or Quality Engineering, R&D, or other related technical roles.
• Working knowledge of quality systems (QSR, ISO 13485) and risk-based quality principles.
• Strong analytical and problem-solving skills with interest in statistical methods.
• Proficiency with standard business tools (Excel, Word, PowerPoint, and statistical software).
• Ability to travel up to 10–20%.

Nice To Haves

• A passion for detailed analysis and problem solving.
• Foundational project management skills and a drive to plan and execute projects that align with business needs.
• Demonstrated ability to independently lead supplier quality initiatives while collaborating effectively across cross functional technical teams.
• The ability to lead with humility, a collaborative mindset, and confidence.
• Strong oral, written, and interpersonal communication skills.
• The ability to present issues, plans, and objectives in a clear, both orally and in writing.
• Versatility, flexibility, and a willingness to work within changing priorities.

Responsibilities

• Own day-to-day supplier quality issues and drive resolution, coordinating with Engineering and Operations, along with communicating and collaborating with suppliers.
• Provide technical and quality support for Incoming Quality Control (IQC) and drive improvement initiatives for supplier and IQC processes.
• Directly support the alignment of supplier inspection and testing methods with Penumbra’s internal methodologies.
• Investigate supplier-related failures (e.g., IQC nonconformances) and support corrective and preventive actions.
• Own Supplier Corrective Actions (SCARs) by driving root cause analysis and corrective action implementation with the supplier.
• Own and manage Second Source Qualifications (SSQs) and Supplier Change (SC) activities, including technical risk assessments and documentation.
• Initiate and manage Supplier Notifications (SNs) and track supplier quality actions to closure.
• Participate in monitoring and trending of supplier performance metrics, contributing to identification of improvement opportunities.
• Coordinate qualification of new suppliers and assist in the ongoing management of the Approved Supplier List (ASL).
• Ensure adherence to Penumbra’s QMS and applicable domestic and international regulations (e.g., QSR, ISO 13485).
• Collaborate cross-functionally to strengthen supplier partnerships and drive continuous improvement in product quality and reliability.
• Represent Supplier Quality Engineering in project teams - owning supplier quality efforts to meet project objectives.
• Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.

Benefits

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level