Medical Device Quality Assurance Engineer (Medical Devices)

Location: Office-based in Austin, Texas, United States

Company

hirify.global is a medical technology company developing clinically differentiated solutions for orthopedics and other applications, with a focus on patient outcomes and workflow transformation.

What you will do

• Evaluate nonconforming materials and determine dispositions through cross-functional engineering review.
• Analyze production data, quality reports, device failures, customer complaints, and nonconformance trends.
• Develop and update quality standards, procedures, and work instructions.
• Author and conduct process and equipment validations, including IQ/OQ/PQ.
• Lead root cause analysis and corrective and preventive action investigations.
• Support Manufacturing and Operations in resolving quality and compliance issues and represent Quality Assurance on the Material Review Board.

Requirements

• Bachelor’s degree in Science or Engineering and 3–5 years of experience.
• Required experience with manufacturing transfers and validation in a regulated environment.
• Experience in medical devices, aeronautics, automotive, or another highly regulated industry.
• Knowledge of manufacturing processes including metrology, precision machining, grinding, product cleaning, and sterilization.
• Knowledge of technical writing, Microsoft Office, and quality standards such as GMP, ISO, FDA, and CMDR; ISO 13485 knowledge is preferred.
• Must already have full-time work authorization in the United States and must not require employment visa sponsorship.

Nice to have

• Knowledge of Solidworks, Solidworks ePDM, Oracle R12, or Agile PLM.
• CQE, Lean, or Six Sigma certification.

Culture & Benefits

• Collaborative quality-focused environment centered on scientific excellence and improved patient outcomes.
• Medical, dental, and vision insurance.
• Spending and savings accounts and a 401(k) plan.
• Vacation, sick leave, holidays, income protection plans, discounted insurance rates, and legal services.
• Requires professional communication, customer service, ethical conduct, and the ability to lift 50 pounds and perform bending, twisting, and overhead lifting.