Supplier Quality Engineer I

As a Supplier Quality Engineer I 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 support 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 for an early-career engineer to build a strong foundation in supplier quality, gain exposure to medical device manufacturing, and grow within a high-impact quality organization. You’ll join a collaborative and growing Quality organization that invests in technical development and career growth.

 

• Support day-to-day supplier quality issues and coordinate with Engineering and Operations to communicate and collaborate with suppliers.

• Provide technical and quality support for Incoming Quality Control (IQC) and contribute to improvement initiatives for supplier and IQC processes.

• Participate in 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.

• Assist in Supplier Corrective Action Requests (SCARs), Second Source Qualifications (SSQs), and Supplier Change (SC) activities, including risk assessments and documentation.

• Initiate and manage Supplier Notifications (SNs) and track supplier quality actions to closure.

• Support the monitoring and trending of supplier performance metrics to identify improvement opportunities.

• Assist with qualification and ongoing management of suppliers on 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.

 

• Bachelor’s degree in engineering, science, or a related field.

• 0–3 years of experience in Quality, Manufacturing, or Engineering; prior exposure to a regulated industry (medical device, pharmaceutical, aerospace, etc.) preferred.

• Foundational knowledge of quality systems (QSR, ISO 13485) and risk-based quality principles.

• Strong analytical and problem-solving skills with an interest in statistical methods.

• Excellent written and verbal communication skills, with the ability to work collaboratively across teams and suppliers.

• Proficiency with standard business tools (Excel, Word, PowerPoint, and statistical software).

 

• Alameda, CA

• Starting Base Salary: $76,000/year to $100,000/year

 

• A passion for detailed analysis and problem solving.

• A desire for growing project management skills and a drive to plan and execute projects that align with business needs.

• The desire to be part of a great team and to support Supplier Quality Engineering on 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. 

• Business travel from 10% - 20%

• 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.