Thermo Fisher Scientific · 10 hours ago
Quality Engineer II
Austin, Texas, USA
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Quality Engineer II to join their Quality Assurance team. In this role, you will ensure compliance with quality standards and regulatory requirements while collaborating with cross-functional teams to drive continuous improvement initiatives and maintain high product quality standards.
Research
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
Bachelor's Degree
2+ years of quality assurance experience in GMP/ISO regulated environments
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
ISO 13485/FDA Lead Auditor certification
ASQ certification (CQE, CQA)
Foreign language skills
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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