Quality Engineer
$60,000–$72,000 year
On-siteBuffalo, New York, United States
Job Summary
Investigate customer complaints, perform root cause analysis, and execute corrective and preventive actions (CAPA) while maintaining accurate quality records. Conduct hands-on shop floor activities including process validations (IQ/OQ/PQ), defect reduction using Lean and Six Sigma tools, and root cause analysis for non-conformances. Support New Product Introduction teams by establishing quality requirements and inspection criteria, and collaborate with Manufacturing, R&D, and cross-functional groups to resolve process variances and drive continuous improvement. Ensure all procedures comply with cGMP, ISO, and FSSC standards while assisting in regulatory audits and sustainability initiatives.
Required Qualifications
- Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Industrial) or a related technical scientific discipline
- 3+ years of hands-on Quality Engineering experience in a manufacturing environment
- Must be able to stand and walk for the duration of the shift
- Occasionally lift or move objects up to 50lbs
- Able to climb on and move barrels and boxes for sampling
Desired Qualifications
- Experience working within a regulated quality system such as ISO 9001, ISO 13485, FSSC 22000, cGMP, or similar
- Experience in a manufacturing environment involving physical products, production processes, and in-process or finished-product inspection
- ASQ Certified Quality Engineer (CQE), Lean Six Sigma Green/Black Belt, or other related certifications
- Experience with Gage R&R, DOE, or other statistical tools
- Experience with Minitab, QMS, ERP, or SPC systems
- Experience investigating, analyzing, and closing non-conformances, customer complaints, and corrective actions within a formal quality system
- Familiarity with process and equipment validation principles, including IQ/OQ/PQ
- Proficiency with Microsoft Office, particularly Excel
- Experience with structured problem-solving methods including 5-Why, Fishbone, 8D, DMAIC, or similar methodologies
- Working knowledge of SPC, process capability, sampling methods, and basic statistical analysis
- Ability to read and interpret technical specifications, drawings, process documentation, and test results and to use common measurement and inspection equipment
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