Supplier Quality Engineer II

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.

• 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.

• 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%.

Location: Alameda, CA

Annual Salary: $90,000 to $121,000

• 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.

• General office, laboratory, and cleanroom environments

• Willingness and ability to work on site. May have business travel from 0% - 25%

• Potential exposure to blood-borne pathogens

• Requires some lifting and moving of up to 25 pounds

• Must be able to move between buildings and floors. 

• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.  

• Must be able to read, prepare emails, and produce documents and spreadsheets.   

• Must be able to move within the office and access file cabinets or supplies, as needed. 

• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.