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Quality Engineer II – Electronics
Company | Penumbra Inc |
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Location | Alameda, CA, USA |
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Salary | $95000 – $127000 |
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Type | Full-Time |
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Degrees | Bachelor’s, Associate’s |
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Experience Level | Mid Level |
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Requirements
- Associate’s or Bachelor’s degree in Engineering, a Life Science, or a related field
- 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment
- Familiarity with QSR, ISO and other applicable regulations and laws required
- Excellent verbal, written, and interpersonal communication skills
- Proficiency with MS Word, Excel, and PowerPoint
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
Preferred Qualifications
- Engineering experience in a manufacturing environment recommended
- Medical device industry preferred
- Experience with Electronic devices and or PCBAs