QA Engineer II

Thermo Fisher Scientific - Austin, TX

Full-time - Entry Level

Austin, TX

Computer and Electronic Product Manufacturing

About the position

The QA Engineer II position is focused on enhancing and maintaining quality systems to ensure that products meet internal, customer, and regulatory standards. The role involves driving quality goals, managing audits, and supporting product compliance, while fostering a culture of continuous improvement and teamwork.

Responsibilities

• Ensure compliance with ISO9001, ISO13485, and FDA 21CFR Part 820 in all systems and procedures.
• Manage the internal audit program and support external audit readiness.
• Trend and report quality data.
• Facilitate Corrective and Preventive Actions (CAPA) and investigations.
• Manage Quality Management System (QMS) deviations and ensure reporting of critical issues.
• Support New Product Introductions (NPI) by collaborating with various teams for product and process compliance.
• Assist in resolving customer complaints and field actions.
• Drive continuous improvement initiatives across the organization.
• Maintain a culture of high employee engagement, teamwork, and flexibility.

Requirements

• Bachelor's degree in a Scientific/Technical field.
• 1-2 years of relevant Quality experience in an ISO 9001, ISO 13485 environment.
• Auditing experience, ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications preferred.
• Knowledge of the US FDA Quality System Regulations and ISO 13485.
• Understanding of Design Control and Risk Management.
• Strong analytical skills and attention to detail.
• Excellent verbal and written communication skills.

Nice-to-haves

• ASQ CQA or ISO 13485 Lead Auditor or Internal Auditor certifications.

Benefits

• Competitive salary
• Annual incentive bonus plan
• 401K with company matching up to 6%