Engineer III, QA

About the Role

As a Quality Engineer III at Thermo Fisher Scientific in Austin, TX, you will help ensure quality excellence and regulatory compliance across manufacturing operations. You will support the mission to enable customers to make the world healthier, cleaner and safer by maintaining robust quality management systems, leading investigations, driving continuous improvement, and ensuring GMP/ISO compliance. The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators.

Responsibilities

• Collaborate with interdepartmental contacts to resolve issues arising from customer complaints or deviations by facilitating investigations, root cause analysis, and corrections/corrective actions to ensure accurate documentation and closure.
• Perform management review, quality reviews, internal audits, approval of procedures, deviations, and change control.
• Review validation plans and completed validations to ensure quality and product requirements are met, and archive records.
• Support NPI projects, ensuring design control requirements are met.
• Lead projects and meetings related to product issues, such as the Material Review Board and Change Control Board, and drive continual process improvement.
• Aid in the identification of continuous improvement opportunities and participate in practical process improvement (PPI) initiatives.
• Perform quality assessments of facility, personnel, and documentation areas to ensure quality and compliance.
• Prepare clearly written business communications, including audit reports, gap assessments, meeting minutes, and customer letters.
• Participate in internal audits, third‑party audits, external customer audits, and agency inspections.
• Foster a quality culture by helping personnel understand the application of policies and controls.
• Provide leadership in planning and execution of activities, acting as a resource and mentor to colleagues (no supervisory duties).
• Serve as a backup for other Quality roles and fulfill other duties as assigned.

Requirements

• Advanced degree plus 3 years of experience, or Bachelor’s degree plus 5 years of experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech).
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, including a drug screen.
• Relocation assistance is not provided.

Preferred Qualifications & Certifications

• Fields of study: Engineering, Life Sciences, Chemistry, or related technical field.
• ASQ certifications (CQE, CQA) and/or Lead Auditor certification from an accredited agency.
• Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, USDA, EMA, etc.).

Skills

• Expertise in quality systems: CAPA and deviation management, change control, risk management and FMEA, document control, internal/external auditing.
• Advanced problem‑solving and root cause analysis abilities.
• Excellent project management capabilities.
• Strong verbal and written communication skills.
• Proficiency with quality management software and Microsoft Office.
• Experience with validation and qualification protocols.
• Knowledge of statistical analysis and quality tools.
• Ability to work both independently and collaboratively.
• Strong attention to detail while maintaining a broad perspective.
• Excellent interpersonal skills for cross‑functional collaboration.

Benefits

• Competitive remuneration.
• Annual incentive plan bonus.
• Healthcare coverage.
• Comprehensive employee benefits package.
• Career and development prospects within an innovative, forward‑thinking organization.
• Company culture that emphasizes integrity, intensity, involvement, and innovation.

Work Schedule & Environment

Standard work schedule: Monday – Friday. The role is based in an office environment with a requirement for some personal protective equipment (safety glasses, gowning, gloves, lab coat, ear plugs, etc.) as needed.