Thermo Fisher Scientific · 9 hours ago
Engineer II, QA Investigator
Lenexa, KS
Full-time
Onsite
Entry, Mid Level
2+ years expThermo Fisher Scientific is a company 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 teams to drive improvements and maintain product quality.
Research
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
Implement corrective actions to maintain our 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
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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