Quality Assurance Engineer (Medical Devices)

Location: Union City, California, United States; onsite

Salary: $136,000–$156,000 annually, depending on experience, plus an annual potential bonus and comprehensive benefits.

Company

hirify.global develops specialty surgical tables and disposable and reusable patient care products for spine and orthopedic procedures.

What you will do

• Provide quality engineering guidance for manufacturing, production, new product introductions, and product modifications.
• Manage internal audits and support external audits conducted by the FDA, Notified Bodies, and corporate stakeholders.
• Process complaints, CAPAs, nonconformances, deviations, and related quality system activities through closure.
• Monitor regulatory compliance and lead continuous improvement initiatives for the quality management system.
• Manage product labeling throughout the lifecycle in collaboration with Regulatory Affairs, Marketing, and Manufacturing.
• Develop and review validation documentation for sterilization, clean manufacturing environments, equipment qualification, inspections, and testing.

Requirements

• Bachelor’s degree in science or a related field with 8–12 years of relevant experience, or a master’s degree with 6+ years, or a PhD with 3+ years.
• Experience with mechanical or electromechanical medical device manufacturing and quality systems.
• Thorough knowledge of ISO standards, FDA QMSR, EU MDR, and applicable medical device regulations.
• Experience with CAPA, complaint processing, NCR, MRB, deviations, IQ/OQ/PQ, sterilization validation, and controlled manufacturing environments.
• Familiarity with ISO/IEC/IEEE 12207, IEC 62304, CAD, solid modeling, GD&T, and basic statistical analysis.
• Strong English verbal and written communication skills are required.

Nice to have

• ASQ CQE or CQA certification.
• ISO 13485 auditor certification.
• Knowledge of Lean manufacturing principles.
• Additional language skills.

Culture & Benefits

• Comprehensive benefits package.
• Annual potential bonus.
• Work with cross-functional teams in a fast-paced medical device environment.
• Opportunities to share knowledge and contribute to continuous improvement.