Sr. Supplier Quality Engineer

About Penumbra

Company description not provided.

Job 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.

Key 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.

Requirements

• Bachelor’s degree in engineering or scientific discipline.
• 5+ years of engineering experience, 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.
• Ability to travel up to 10%.

Preferred Qualifications

• In depth knowledge of QSR, ISO and other applicable regulations.

Salary

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