Thermo Fisher Scientific · 1 day ago
Engineer II, QA Investigator
Lenexa, KS
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is dedicated to making the world healthier, cleaner, and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements, collaborating with cross-functional teams to drive improvements and maintain high product quality standards.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Ensure compliance with quality standards and regulatory requirements across our 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 plus 2 years of quality experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology
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
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 ability to prioritize effectively
Ability to work in clean room environments when required
Must be legally authorized to work in the United States without sponsorship
Preferred
Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field
ISO 13485/FDA Lead Auditor certification beneficial
ASQ certification (CQE, CQA) advantageous
Foreign language skills beneficial
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
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
Company data provided by crunchbase