Medical Device Quality Assurance Engineer (Medtech)

TL;DR

Medical Device Quality Assurance Engineer (Medtech): Utilizing engineering principles to design, implement, and maintain quality assurance procedures for medical devices with an accent on compliance with FDA, ISO 13485, and GMP standards. Focus on evaluating nonconforming materials, leading root cause analysis, process validations, and supporting manufacturing operations.

Location: Austin, Texas (office-based). Must have full-time work authorization in the United States without requiring sponsorship.

Company

Innovation-driven medical technology growth company developing clinically differentiated solutions for orthopedics and beyond.

What you will do

• Evaluate nonconforming material and disposition based on cross-functional engineering review.
• Analyze reports and production data to identify trends.
• Initiate, develop, and recommend updates to quality standards and procedures.
• Author and conduct process and equipment validations (IQ/OQ/PQ).
• Assure compliance to GMP, ISO, FDA, and other standards.
• Lead root cause analysis, corrective and preventive actions.
• Support Manufacturing and Operations on quality and compliance issues.

Requirements

• Bachelor’s in Science or Engineering + 3-5 years experience.
• Experience with manufacturing transfers and validation (IQ/OQ/PQ) in regulated environment.
• Background in Medical Device, Aeronautics, Automotive or similar highly regulated industry.
• Knowledge of manufacturing processes: metrology, precision machining, grinding, product cleaning, sterilization.
• Technical writing skills and Microsoft Office proficiency.
• Fluent English communication (written and verbal).
• Ability to lift 50 lbs, bend, twist, and lift overhead.

Nice to have

• Knowledge of ISO 13485.
• CQE, Lean, or Six Sigma Certification.
• Solidworks, Solidworks ePDM, Oracle R12, Agile PLM.

Culture & Benefits

• Medical, Dental, Vision Insurance.
• 401(k) Plan, Spending and Savings Accounts.
• Vacation, Sick Leave, Holidays.
• Income Protection Plans, Discounted Insurance Rates, Legal Services.