Medical Device Sr. Supplier Quality Engineer (Hayward)

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 Penumbras 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 :

Bachelors 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.

Ability to travel up to 25%.

Additional Qualifications :

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.

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 Penumbras commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.