Sr. Supplier Quality Engineer

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.

• 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

Minimum education and experience:

• Bachelor’s degree in engineering or scientific discipline with
• 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.

• In depth knowledge of QSR, ISO and other applicable regulations and standards.
• Training and experience in performing supplier audits is a plus.
• ASQ CQE certification is a plus.
• Experience with Electronics and PCBAs are a plus.
• A passion for detailed analysis and problem solving.
• Strong project management skills and a proactive drive to plan and execute projects that align with business needs.
• The desire to be part of a great team and to represent 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, compelling way, 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%
• Requires some lifting and moving of up to 25 pounds
• Potential exposure to blood-borne pathogens
• 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…