Quality Engineer (Medical Devices)

Location: Austin, Texas, United States. Applicants must already have full-time work authorization in the United States and must not require employment visa sponsorship.

Company

hirify.global is a medical technology company developing clinically differentiated products, services, and integrated technologies for orthopedics and related applications.

What you will do

• Prepare, implement, and maintain Master Quality and Master Validation Plans, including IQ, OQ, and PQ activities.
• Conduct quality analysis, audits, inspections, failure investigations, customer complaint reviews, and corrective and preventive actions.
• Drive continuous improvement through 5S, Kaizen, Lean methods, SPC, capability studies, Gage R&R, DOE, and COPQ initiatives.
• Support product launches, engineering changes, production transfers, incoming and outgoing quality functions, and supplier corrective actions.
• Maintain quality documentation, nonconformance systems, reporting procedures, and quality performance scorecards.
• Support FDA, Notified Body, internal, and other third-party audits while collaborating with Engineering, Operations, Manufacturing, and Quality teams.

Requirements

• Bachelor’s degree in engineering or another technical discipline, or equivalent experience.
• At least 2 years of experience in quality engineering or a related field.
• Knowledge of FDA/GMP, CMDR, MDD, and ISO 13485 quality standards.
• Experience with FMEA, QFD, SPC, risk analysis, DOE, TQM, statistical analysis, problem-solving techniques, and GD&T.
• Strong written and verbal communication skills, technical project management ability, and proficiency with Word and Excel.
• Full-time U.S. work authorization is required; hirify.global does not provide employment visa sponsorship.

Nice to have

• ASQ certification with active local membership.
• Lean Six Sigma Green Belt or higher.
• Experience in the medical device industry and lean manufacturing.
• Agile or Oracle experience.
• Knowledge of U.S. and international quality system regulations and experience interpreting engineering drawings, BOMs, and process diagrams.

Culture & Benefits

• Focus on collaboration, scientific excellence, continuous improvement, and better patient outcomes.
• Medical, dental, and vision insurance.
• Spending and savings accounts, income protection plans, and discounted insurance rates.
• 401(k) plan, vacation, sick leave, and holidays.
• Legal services and opportunities for associate growth and development.