Senior Quality Engineer for Medical Device Suppliers

General Summary

Join Penumbra as a Senior Quality Engineer specializing in Supplier Quality. In this critical role, you will be at the forefront of ensuring a robust and compliant supply chain that guarantees the highest quality standards for our innovative medical devices. Collaborate with cross-functional teams to tackle supplier quality challenges and drive enhancements in performance, capacity, and cost-effectiveness.

Specific Duties and Responsibilities

• Provide expert technical and quality support for Incoming Quality Control (IQC) while resolving day-to-day quality challenges and leading initiatives for supplier improvements.
• Lead the Supplier Second Source Qualifications (SSQs) and Supplier Changes (SCs), conducting thorough technical assessments while collaborating with suppliers and internal teams to identify and mitigate risks.
• Represent Supplier Quality Engineering on project teams, coordinating supplier efforts to achieve project goals.
• Manage and expedite the closure of Supplier Corrective Actions (SCARs) while supporting root cause analysis and corrective action implementation.
• Align supplier inspection and testing programs with Penumbra’s quality methodologies.
• Investigate supplier-related failures and lead both immediate and long-term solutions in partnership with suppliers and internal teams.
• Collaborate with suppliers to enhance technical processes, reliability, and quality controls to consistently meet Penumbra’s stringent quality standards.
• Oversee the qualification and development of new or existing suppliers.
• Design experiments and tests, applying statistical analysis to interpret engineering data effectively.
• Manage the Approved Supplier List proactively.
• Mentor junior Supplier Quality Engineers in their responsibilities.
• Develop, monitor, and analyze supplier performance metrics to identify trends, risks, and appropriate actions.
• Initiate and lead continuous improvement projects tailored to supplier quality compliance and quality management systems (QMS).

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

Position Qualifications

Additional Qualifications :

What We Offer

At Penumbra, you will work within a collaborative environment that fosters learning and rewards performance. Be part of a team dedicated to revolutionizing treatment for some of the world’s most devastating diseases. Our competitive benefits package includes medical, dental, vision, life insurance, short and long-term disability, a 401(k) plan with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays, a minimum of fifteen days of vacation that increases with tenure, plus paid sick time, all compliant with applicable laws.

Penumbras, Inc. is headquartered in Alameda, California, and focuses on innovative therapies in healthcare. Our commitment to quality and excellence drives us to create and deliver novel products addressing significant unmet medical needs. You will join an excellent team committed to making a difference.

Penumbras, Inc. values diversity and equal opportunity in the workplace. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by law.