Quality Engineer I — Medical Devices QA & Compliance

Penumbra, Inc.; Alameda (CA); On-site; USD 80,000 - 105,000; Full time

Job summary

Penumbra, Inc. in Alameda, CA, is seeking a Development Quality Engineer I to work with product development teams to design and qualify new life-saving products.

You will help develop quality system elements to ensure high quality and regulatory compliance, and help bring products safely and efficiently to market. The role involves developing testing methodologies, quality sampling systems, and documentation, performing failure analyses, and ensuring adherence to QMS and applicable standards.

Qualifications

• 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

• Participate in the product development and qualification activities for new and existing products
• Participate in Product Development teams
• Develop testing, inspection methodology, and documentation for new and existing products
• Design and install quality sampling systems and procedures utilizing statistical analysis
• Design or specify inspection and testing equipment to meet product requirements
• Perform failure analyses and defect investigations
• Analyze and apply design control standards
• Interface with other internal departments, customers, and suppliers on product and quality-related issues
• Adhere to the Company’s Quality Management System (QMS) and applicable regulations and standards
• Understand security, privacy, and compliance principles and adhere to applicable regulations and procedures
• Ensure other members of the department follow the QMS and regulations
• Perform other work-related duties as assigned

Education

Associate or Bachelor's in Engineering, Life Science or related field with quality engineering experience

Job description

Penumbra, Inc. in Alameda, CA, is seeking a Development Quality Engineer I to work with product development teams to design and qualify new life-saving products.

You will help develop quality system elements to ensure high quality and regulatory compliance, and help bring products safely and efficiently to market. The role involves developing testing methodologies, quality sampling systems, and documentation, performing failure analyses, and ensuring adherence to QMS and applicable standards.