Thermo Fisher Scientific · 19 hours ago
Quality Engineer II
Austin, TX
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a global leader in providing solutions that make the world healthier, cleaner, and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across manufacturing operations while collaborating with cross-functional teams to drive continuous improvement initiatives and maintain high product quality standards.
BiotechnologyMedical DeviceCloud ComputingEnterprise SoftwareConsultingHealthcareLife ScienceBioinformaticsCloud Data ServicesHealth CareManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Ensure compliance with quality standards and regulatory requirements across manufacturing operations
Collaborate with cross-functional teams to drive continuous improvement initiatives
Lead investigations and implement corrective actions to maintain high standards of product quality
Qualification
Required
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screen
Bachelor's Degree required
2+ years of quality assurance experience in GMP/ISO regulated environments required
Strong knowledge of quality systems, cGMP regulations, and standards, including ISO 13485, 21 CFR Part 820
Expertise in quality tools and methodologies, including risk management, root cause analysis, CAPA, and change control
Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions
Excellent documentation and technical writing skills for developing SOPs, protocols, and reports
Strong proficiency in quality management software (TrackWise, SAP QM, etc.) and Microsoft Office suite
Experience conducting internal audits and supporting external regulatory inspections
Experience with incoming and final inspection, sampling plans, and approval workflows
Demonstrated ability to build consensus and collaborate across functions
Strong verbal and written communication skills
Ability to work independently while contributing effectively in team environments
Strong attention to detail with analytical and problem-solving capabilities
Experience with statistical analysis tools and quality metrics reporting
Project management skills and the ability to prioritize effectively
Ability to work in clean room environments when required
Preferred
Experience in a Medical devices, pharmaceuticals, or biotechnology environment preferred
ISO 13485/FDA Lead Auditor certification is beneficial
ASQ certification (CQE, CQA) is advantageous
Foreign language skills are beneficial
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$19.77BKey Investors
National Grid
2026-02-09Post Ipo Debt· $3.8B
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
2026-02-11
Company data provided by crunchbase