Medical Device Sr. Supplier Quality Engineer

Job Description

General Summary

As a Senior Supplier Quality Engineer at Penumbra, you will lead efforts in ensuring a robust and compliant supply chain in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. You will work closely with cross-functional teams to resolve supplier quality issues and implement improvements to supplier performance, quality, capacity, and cost. You will be looked to drive resolution of quality issues, and lead strategic initiatives such as supplier qualifications and risk mitigation efforts.

Specific Duties and Responsibilities

• Provide technical and quality support for IQC in solving day-to-day quality issues. Identify and lead Supplier or IQC improvements and drive projects.
• Lead Supplier Second Source Qualifications (SSQs) and Supplier Changes (SCs) to closure, including performing technical assessment. Work with suppliers and internal cross-functional teams to appropriately identify and mitigate risks for SSQs and SCs.
• Lead or participate in project teams representing Supplier Quality Engineering - coordinating the supplier quality efforts to meet project objectives.
• Drive closure of Supplier Corrective Actions (SCARs) and support root cause analysis and corrective action implementation with the supplier.
• Align supplier inspection / testing programs with Penumbra’s methodologies.
• Investigate supplier-related failures (e.g., IQC NCRs) and drive short and long-term resolution with suppliers and internal teams.
• Partner with suppliers to continually improve technical processes, reliability, and quality controls to meet Penumbra's quality standards.
• Lead the qualification and development of new or current suppliers.
• Design experiments and tests, and apply statistical rationale to analyze, and interpret engineering test data.
• Lead in the management of the Approved Supplier List.
• Mentor junior Supplier Quality Engineer(s) in support of Supplier Quality Engineering responsibilities.
• Lead the development, monitoring, and analysis of supplier performance metrics. Identify trends and risks and independently take appropriate actions.
• Identify and lead continuous improvement efforts related to supplier quality compliance or QMS.

Starting Base Salary : $119,000 to $166,000 annually

Position Qualifications

Minimum education and experience :

Additional Qualifications :

What We Offer

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.