Quality Engineer
Listed on 2026-07-19
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Entry-Level Quality Engineer
Location:
Austin, TX (78754)
Schedule:
Full-time | Monday–Friday | 8:00 AM–5:00 PM | On-site
Launch Your Engineering Career in Medical Devices
International Biomedical Ltd. is a leading designer and manufacturer of innovative medical devices that improve patient care around the world. Our products—including neonatal transport systems, nitric oxide delivery devices, and breast pumps—support healthcare professionals in delivering life‑saving care.
We're looking for a motivated, detail-oriented Quality Engineer to join our growing Quality team. This is an outstanding opportunity for a recent engineering graduate or early‑career professional who is eager to develop hands‑on experience in medical device quality systems, manufacturing, and regulatory compliance.
You’ll work alongside experienced quality and engineering professionals, gaining valuable exposure to FDA‑regulated manufacturing while helping ensure our products meet the highest standards of safety and quality.
What You'll DoAs a Quality Engineer, you will:
- Support quality assurance activities throughout the manufacturing process.
- Investigate product and supplier quality issues and assist with root cause analysis and corrective actions.
- Help develop inspection methods and quality control procedures for new and existing products.
- Collect, analyze, and report quality data to identify trends and improvement opportunities.
- Collaborate with Engineering, Manufacturing, Purchasing, and Suppliers to resolve quality concerns.
- Assist with supplier quality management and performance monitoring.
- Participate in internal quality audits and continuous improvement initiatives.
- Help ensure compliance with FDA Quality System Regulations, ISO 13485, and other applicable quality standards.
- Maintain quality documentation and support regulatory compliance activities.
Required Qualifications
- Bachelor's degree in Engineering or a related technical discipline.
- Strong analytical and problem‑solving skills.
- Excellent written and verbal communication skills.
- Exceptional attention to detail and organizational skills.
- Proficiency with Microsoft Excel and other Microsoft Office applications.
- Ability to work effectively in a collaborative, fast‑paced manufacturing environment.
- Internship, co‑op, laboratory, or manufacturing experience.
- Exposure to quality tools such as Root Cause Analysis, 5 Why, FMEA, SPC, or Lean Manufacturing.
- Familiarity with FDA Quality System Regulations, ISO 13485, or medical device manufacturing is a plus—but not required.
- Make a meaningful impact by helping manufacture products that improve patient care worldwide.
- Learn from experienced Quality and Regulatory professionals.
- Gain valuable experience in the highly regulated medical device industry.
- Work in a collaborative environment focused on innovation and continuous improvement.
- Build a strong foundation for long‑term career growth in Quality Engineering.
- Competitive compensation
- 401(k)
- Medical and dental insurance
- Paid time off
- Employee Assistance Program
- Opportunities for professional growth and development
Director of Quality Assurance & Regulatory Affairs
Work LocationAustin, Texas (On-site)
We Encourage You to ApplyIf you're a recent graduate or early‑career engineer who's excited about quality, manufacturing, and making a difference through medical technology, we'd love to hear from you. Even if you don't meet every preferred qualification, we encourage you to apply if you believe you'd be a strong addition to our team.
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