Senior Supplier Quality & Compliance Analyst

Penumbra seeks a Senior Supplier Quality & Compliance Analyst to oversee external supplier management through audits, evaluations, and compliance assessments. The role involves leading audit programs, developing quality agreements, and driving supplier improvements aligned with regulatory standards and business objectives.

Responsibilities

• Organize and lead external supplier audit program including logistics and documentation
• Conduct supplier audits as auditor or lead auditor and author compliance reports
• Develop and maintain strategic audit plans and supplier audit schedules
• Evaluate supplier corrective action responses and manage nonconformance resolution
• Prepare, review, and update Supplier Quality Agreements with internal and external stakeholders

Requirements

• Bachelor's degree in science or related field
• 7+ years quality systems experience, preferably medical device
• Knowledge of QSR, ISO, and applicable regulations
• Statistical methodologies and data analysis experience
• cGMP familiarity in medical device or equivalent industry
• Strong written, oral, and interpersonal communication skills
• Proficiency with MS Word and Excel