Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionLocation/Division-Specific Information:Austin, TX. Relocation assistance is NOT provided.
*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.
Discover Impactful Work:Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner, and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.
Keys to Success:Education and Experience- Bachelor's Degree required.
- 2+ years of quality assurance experience in GMP/ISO regulated environments required.
- Experience in a Medical devices, pharmaceuticals, or biotechnology environment preferred.
- ISO 13485/FDA Lead Auditor certification is beneficial.
- ASQ certification (CQE, CQA)is advantageous.
- 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.
- Foreign language skills are beneficial.
Benefits:We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
