search Browse Jobs
Senior Supplier Quality & Compliance AnalystPenumbra, Inc. · Alameda, CA
Penumbra, Inc. logo

Penumbra, Inc.

company page ↗

Senior Supplier Quality & Compliance Analyst

🗓️ Posted 2026-10-13 Alameda, CA External Hybrid Manufacturing Transport Logistics
💰 Salary 9,417 CAD–12,500 CAD/mo (113,000 CAD–150,000 CAD/yr) 📊 Market 6,500 CAD–8,500 CAD/mo

About the Company

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. Members of the Penumbra team agree that this is where their work has meaning -- we are transforming the treatment of some of the world's most devastating conditions. Penumbra is where everyone's ideas matter, and where learning and growth are constant. No. 5 on the Greater Bay Area Manufacturers List, San Francisco Business Times, 2020 100 Fastest-Growing Companies, Fortune, 2019 Review our community guidelines for LinkedIn here: https://bit.ly/2Jmbw83. Medical Equipment Manufacturing Specialties: Neurointerventional devices, Stroke treatment, Vascular access, Thrombectomy systems, Interventional radiology, Medical device innovation

Responsibilities

  • ● As a Senior Supplier Quality & Compliance Analyst, you will engage in the management of external suppliers through supplier audits and periodic evaluations of suppliers. The Senior Supplier Quality & Compliance Analyst is responsible for leading ongoing supplier quality activities is responsible for leading ongoing supplier quality related activities agreements, acting as lead auditor during supplier audits and supporting supplier development initiatives, in alignment with Procurement and Supplier Quality Engineering, to improve quality and meet business objectives.
  • ● What You'll Work On
  • ● 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 against applicable requirements and determine or recommend 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 selected for audit, referencing applicable procedures and aligning with Supplier Quality Engineering on audit scope.
  • ● Engineering on audit scope. Assess supplier changes and review previous audits and supplier performance.
  • ● Conduct audit activities in a professional manner. Review supplier procedures against internal and external compliance requirements.
  • ● Author supplier audit reports following QMS requirements and provide a summary of the audit. Draw conclusions regarding compliance status and present potential findings for leadership review. Provide well-founded recommendations for improvement. Run closing meetings and review process for audit follow-up activities.
  • ● Evaluate the adequacy of supplier corrective-action responses and determine whether additional evidence, remediation, or escalation is required to ensure any nonconformances are sufficiently addressed.
  • ● Manage the development and maintenance of the supplier audit schedule in alignment with leadership and Supplier Quality Engineering to support ongoing quality improvement efforts and business objectives.
  • ● Lead the preparation, review, and update of Supplier Quality Agreements by developing criteria, ensuring alignment with regulatory standards, and collaborating with suppliers to address quality issues.
  • ● Maintain the Approved Distributor List (ADL)
  • ● Proactively identify and collaborate with suppliers to resolve day-to-day quality and compliance issues and address potential issues before they escalate.
  • ● Maintain records that support Supplier Quality.
  • ● Own, manage, and drive NCRs and CAPAs, as necessary, in support of Supplier Quality Compliance functions.
  • ● Develop, recommend, and implement improvements to supplier quality procedures, work instructions, and controls based on audit trends, compliance risks, and supplier performance data. Manage and release ECOs to support process improvements and resolve supplier-related issues.
  • ● Interface with other internal departments, customers, and suppliers on quality-related issues
  • ● Remain current on industry requirements and trends related to quality compliance in the medical device industry.
  • ● Responsible for timely communication with suppliers and distributors.