Quality Engineer II
$75,000–$80,000 year
On-siteArden, North Carolina, United States
Job Summary
Quality Engineer II applies engineering methodologies and analytics to initiate, implement, and manage the Master Validation Plan within the facility; aims to improve operational effectiveness by refining procedures to optimize validations; serves as SME for new product and machine validations; designs protocols using sampling techniques and design of experiments with statistical rationale; conducts validation/qualification tests on equipment, processes or software per internal/external standards; performs sterilization validations and supports the master sterilization plan; develops aging studies for packaging and coordinates testing, analyzes data, and documents results; leverages Word, Excel, SAP, Minitab and other tools to manage and analyze data; provides analysis and interpretation of report data; leads Risk Analysis; responsible for KPI improvement on the production floor; SME for Change Control; plus related duties as assigned.
Required Qualifications
- Bachelor’s degree in Engineering or other technical field from a four-year college or university is required.
- Four to six years of experience in the Quality field is required.
- Three to five years of experience in a manufacturing environment preferred.
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