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Quality Engineer III - Catheters
Manufacturing Transport Logistics
💰 Salary Not shared
📊 Market NA
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 III will independently develop and implement appropriate quality system elements to maintain a high level of quality for new and existing products and ensure compliance with applicable regulations and standards.
- ● This role addresses problems of advanced scope where the analysis of situations or data requires a review of identifiable factors. The Quality Engineer III will exercise sound judgment to determine appropriate actions and will communicate and implement quality objectives across the organization.
- ● Specific Duties and Responsibilities
- ● Collaborate on and/or help lead development and qualification activities for new and existing products.
- ● Collaborate on and/or help lead the development of testing and inspection methodologies and documentation for new and existing products.
- ● Collaborate on and/or help lead Quality Objective teams.
- ● Design and implement quality control 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 revisions to specifications.
- ● Partner with other engineering departments, customers, and suppliers to address quality-related issues.
- ● Collaborate on and/or help lead the development of standard operating procedures.
- ● Facilitate and perform internal audits.
- ● Perform responsibilities required by the Quality System and other duties as assigned or requested.
- ● Provide guidance to junior Quality Engineers and interns in support of departmental functions.
- ● Adhere to the Company's Quality Management System (QMS), as well as applicable domestic and global quality system regulations, standards, and procedures.
- ● Understand relevant security, privacy, and compliance principles and adhere to applicable Company regulations, standards, and procedures.
- ● Ensure that other department members follow the QMS and applicable regulations, standards, and procedures.
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