Supplier Quality Engineer (Medical Device)

TL;DR

Supplier Quality Engineer (Medical Device): Design, implement, and maintain quality assurance procedures for supplier materials and manufacturing processes with an accent on compliance with ISO 13485, FDA, GMP, and other regulations. Focus on evaluating nonconforming materials, leading root cause analysis, corrective actions, and process validations to ensure product safety and quality.

Location: Office based in Austin, TX, USA. Must have full-time work authorization in the United States without requiring sponsorship.

Company

Innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions for orthopedics and active lifestyles.

What you will do

• Evaluate nonconforming materials and disposition based on cross-functional engineering review.
• Analyze reports and production data to identify trends in quality issues.
• Initiate and recommend updates to quality standards and procedures.
• Author and conduct process and equipment validations.
• Assure compliance with internal and external standards like GMP, ISO, FDA.
• Lead root cause analysis, corrective and preventive actions.
• Support Manufacturing and Operations on quality and compliance issues.

Requirements

• Bachelor’s in Science or Engineering and 3+ years of experience in Medical Device, Aeronautics, Automotive or other highly regulated industry.
• Knowledge of ISO 13485 quality standards preferred.
• Basic knowledge of manufacturing processes: metrology, precision machining, grinding, product cleaning, sterilization.
• Knowledge of Microsoft Office Suite; preferred Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.
• Must communicate in English clearly and fluently, both written and verbal.
• Office based in Austin, TX; able to lift 50 lbs, bend, twist, lift overhead.

Nice to have

• CQE, Lean, or Six Sigma Certification.
• Certification as an auditor.
• Knowledge of technical writing quality and best practices.

Culture & Benefits

• Culture of continuous improvement, global talent, and innovation.
• Equal employment opportunities based on merit and experience.
• Reasonable accommodations for beliefs and practices.