Quality Engineer

Role overview

International Biomedical Ltd. is hiring an entry-level Quality Engineer in Austin, Texas (78754). This is a full-time, on-site role with a Monday to Friday schedule from 8:00 AM to 5:00 PM.

The company designs and manufactures advanced medical devices that help improve patient care across the world, including neonatal transport systems, nitric oxide delivery equipment, and breast pumps. The position is intended for a recent engineering graduate or an early-career professional who wants practical experience in medical device quality, manufacturing, and regulatory compliance.

In this role, you will partner with experienced quality and engineering teams in an FDA-regulated manufacturing environment and contribute to making sure products meet strong safety and quality standards.

Key responsibilities

• Support quality assurance work across the manufacturing workflow.
• Look into product and supplier quality concerns and assist with identifying root causes and corrective actions.
• Contribute to building inspection methods and quality control procedures for both new and existing products.
• Gather, review, and present quality data to spot trends and improvement opportunities.
• Work with Engineering, Manufacturing, Purchasing, and suppliers to resolve quality issues.
• Help manage supplier quality and track supplier performance.
• Take part in internal quality audits and ongoing improvement efforts.
• Assist in maintaining compliance with FDA Quality System Regulations, ISO 13485, and other relevant standards.
• Keep quality records updated and support regulatory compliance tasks.

Requirements

• A bachelor’s degree in Engineering or another related technical field.
• Strong ability to analyze problems and develop practical solutions.
• Good written and spoken communication skills.
• Careful attention to detail along with solid organizational habits.
• Comfort using Microsoft Excel and other Microsoft Office tools.
• Ability to collaborate effectively in a busy, fast-moving manufacturing setting.

Preferred background

• Internship, co-op, lab, or manufacturing exposure is preferred.
• Experience with quality methods such as Root Cause Analysis, 5 Whys, FMEA, SPC, or Lean Manufacturing is helpful.
• Knowledge of FDA Quality System Regulations, ISO 13485, or medical device manufacturing is an added advantage, but not mandatory.

Why this role stands out

• Contribute to products that support better patient care worldwide.
• Learn directly from experienced Quality and Regulatory professionals.
• Build experience in a tightly regulated medical device industry.
• Join a team that values collaboration, innovation, and continuous improvement.
• Develop a strong base for long-term growth in Quality Engineering.

Benefits

• Competitive compensation.
• 401(k) retirement plan.
• Medical and dental coverage.
• Paid time off.
• Employee Assistance Program.
• Professional development and growth opportunities.

Reporting line and work location

This role reports to the Director of Quality Assurance & Regulatory Affairs. The job is based in Austin, Texas, and requires on-site work.

Application note

Applicants who are recent graduates or early-career engineers with an interest in quality, manufacturing, and medical technology are encouraged to apply. Candidates who do not meet every preferred qualification may still be considered if they can add value to the team.