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.

*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).

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.