Senior Supplier Quality & Compliance Auditor

Penumbra, Inc.; Alameda (CA); On-site; USD 113,000 - 150,000; Full time

Benefits offered by this job

Benefits package

Equity program

Job summary

Penumbra, Inc. in Alameda, CA seeks a Senior Supplier Quality & Compliance Analyst to manage external supplier audits, evaluate supplier performance, and drive quality improvements across the supply base.

You will lead audit teams, develop audit plans, and ensure compliance with QMS and regulatory standards. The role requires a science degree and 7+ years in quality systems within medical devices, plus experience with NCRs, CAPAs, and supplier quality agreements.

Qualifications

• Bachelor's degree in science or related field; 7+ years of quality systems experience, preferably in a medical device environment.
• Experience in statistical methodologies and analysis.
• Working knowledge of the QSR, ISO and other applicable regulations and laws.
• Ability to manage multiple, complex priorities within demanding timeframes with attention to detail.
• Familiar with current Good Manufacturing Practices within a medical device environment.
• ASQ CQA certification preferred.

Responsibilities

• Organize and facilitate the external supplier audit program by analyzing data, coordinating audit logistics, and ensuring documentation is completed per QMS requirements.
• Independently analyze supplier compliance and determine appropriate audit findings and follow-up actions.
• Act as auditor/lead auditor within the designated auditing team on supplier audits.
• Develop strategic audit plans for suppliers, aligning with Supplier Quality Engineering on scope.
• Review supplier procedures against internal and external compliance requirements.
• Author supplier audit reports and provide recommendations for improvement; run closing meetings.
• Evaluate supplier corrective-action responses and determine need for escalation.
• Maintain the supplier audit schedule and update Supplier Quality Agreements as needed.
• Mentor junior Supplier Quality & Compliance Analysts.

Skills

Quality systems

Statistical analysis

Regulatory knowledge

Multitasking

Communication

Education

Bachelor's degree in science or related field

Tools

MS Word

MS Excel

PowerPoint

Job description

Penumbra, Inc. in Alameda, CA seeks a Senior Supplier Quality & Compliance Analyst to manage external supplier audits, evaluate supplier performance, and drive quality improvements across the supply base.

You will lead audit teams, develop audit plans, and ensure compliance with QMS and regulatory standards. The role requires a science degree and 7+ years in quality systems within medical devices, plus experience with NCRs, CAPAs, and supplier quality agreements.