Supplier Quality Engineer I at Penumbra

Alameda, California, United States -

Full Time

Start Date

Immediate

Expiry Date

28 Jan, 26

Salary

100000.0

Posted On

30 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Systems, Analytical Skills, Problem Solving, Statistical Methods, Communication Skills, Collaboration, Technical Support, Risk Assessments, Supplier Management, Performance Monitoring, Corrective Actions, Process Improvement, Documentation, Regulatory Compliance, Project Management, Flexibility

Industry

Medical Equipment Manufacturing

Description

General Summary 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. What You’ll Work On • 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. Position Qualifications • 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). Location and Pay • Alameda, CA • Starting Base Salary: $76,000/year to $100,000/year What You Bring • 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. Working Conditions • 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. \n \n What We Offer •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, an employee stock purchase plan, 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.

Responsibilities

The Supplier Quality Engineer I will support day-to-day supplier quality issues and collaborate with cross-functional teams to ensure compliance with quality standards. Responsibilities include investigating supplier-related failures, managing corrective actions, and monitoring supplier performance metrics.