Development Quality Engineer I (Medical Devices)

Location: Alameda, California, United States; Workplace: On-site

Company

Development and qualification of life-saving medical devices.

What you will do

• Participate in product development, qualification activities, and product development teams for new and existing products.
• Develop testing and inspection methodologies, documentation, and quality sampling systems using statistical analysis.
• Design or specify inspection and testing equipment to meet product requirements.
• Perform failure analyses, defect investigations, and design control activities.
• Recommend revisions to specifications, procedures, and work instructions to improve device design and manufacturing processes.
• Collaborate with internal departments, customers, and suppliers on product and quality-related issues.

Requirements

• Associate’s or bachelor’s degree in engineering, life science, or a related field, plus quality engineering or relevant experience, preferably in a medical device environment.
• Familiarity with QSR, ISO, and other applicable regulations and laws.
• Strong verbal, written, and interpersonal communication skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• Ability to work in office, laboratory, and cleanroom environments and move between buildings and floors.
• Ability to lift and move up to 25 pounds and work with a computer or standard office equipment for extended periods.

Culture & Benefits

• Competitive compensation package.
• Benefits and equity program, when applicable.
• Work across office, laboratory, and cleanroom environments.
• Potential exposure to blood-borne pathogens.