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Quality Engineer IIPenumbra, Inc. · Alameda, CA
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Penumbra, Inc.

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Quality Engineer II

🗓️ Posted 2026-07-21 Alameda, CA External Hybrid Manufacturing Transport Logistics
💰 Salary Not shared 📊 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

  • ● General Summary
  • ● The Quality Engineer II develops and implements appropriate quality system elements to ensure the high-quality level of new and existing products as well as their compliance with applicable regulations and standards. Work with problems of moderate scope where the analysis of situation or data requires a review of identifiable factors. Exercise judgment to determine appropriate action. Communicate and implement quality objectives.
  • ● Specific Duties and Responsibilities
  • ● Collaborate in the development and qualification activities for new and existing products
  • ● Collaborate in the development of testing and inspection methodology and documentation for new and existing products
  • ● Collaborate on Quality Objective teams
  • ● Design and install QC process sampling systems, procedures, and statistical techniques
  • ● Design or specify inspection and testing mechanisms and equipment
  • ● Perform failure analyses and defect investigations
  • ● Analyze production limitations and standards
  • ● Recommend revision of specifications
  • ● Interface with other engineering departments within the company, customers, and suppliers on quality related issues
  • ● Collaborate in the development of standard operating procedures
  • ● Facilitate and perform internal audits
  • ● Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
  • ● Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
  • ● Ensure other members of the department follow the QMS, regulations, standards, and procedures.
  • ● Perform other work-related duties as assigned
  • ● Indicates an essential function of the role