Sr. Development Quality Engineer (Medical Devices)

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

Company

hirify.global develops life-saving medical products in a regulated medical-device environment.

What you will do

• Lead quality engineering activities for the development and qualification of new and existing products.
• Coordinate quality efforts within project teams supporting product design, development, and continuous improvement.
• Design and implement inspection, testing, evaluation, and measurement methods, including method validation.
• Monitor design controls, define success measurements, and maintain compliance with regulatory and industry requirements.
• Analyze quality results, perform statistical analysis, and recommend corrective and preventive actions.
• Support FDA inspections, notified body audits, quality-system activities, and standard operating procedure development.

Requirements

• Bachelor’s degree in engineering, life science, or a related field, with 5+ years of relevant experience, including quality assurance and ISO experience, or an equivalent combination of education and experience.
• Knowledge of engineering and scientific principles, quality systems, design controls, and regulatory requirements.
• Strong oral, written, and interpersonal communication skills, with a high degree of accuracy and attention to detail.
• Proficiency with computers and Microsoft Word, Excel, and PowerPoint.
• Ability to prioritize multiple projects and work in office, laboratory, and cleanroom environments.

Nice to have

• Advanced degree.
• Experience with auditing, design review, sterilization, project management, or product development.
• Experience in medical devices, pharmaceuticals, biotechnology, or another regulated industry.

Culture & Benefits

• Competitive compensation package with benefits and equity when applicable.
• Business travel of approximately 0–10%.
• Work across office, laboratory, and cleanroom environments.
• Potential exposure to blood-borne pathogens and occasional lifting or movement of items up to 25 pounds.