Quality Engineer
Description
Quality Assurance Engineer I
$38.50-$43.50hr
6 month contract (may be extended)
7am-3:30pm
Will be responsible for resolving day to day floor concerns and escalate to management, report on KPIs and contribute and present quality metrics during Management review, performing root cause analyses and managing CAPAs for Quality Problem Reports, Material Reviews, Product Complaints, and Non-Conforming products.
• Resolves day-to-day floor concerns and escalates to management as appropriate.
• Contributes and presents quality metrics during Management Review.
• Report on Key Performance Indicators (KPIs) and collate data for monitoring targets.
• Gather data on performance metrics to facilitate the review of program/ product effectiveness, efficacy, and
actions for adherence to quality.
• Assign CAPAs to impacted departments. Follow-up on CAPA completion by assisting in implementing
corrective or preventative actions (CAPA) to ensure product quality.
• Report Root Cause Failure Analysis (RCFA) findings to management, including on-going
corrective/preventive actions, and the effectiveness of those actions put into practice.
• Complete preliminary review for Material Review Reports (MRR).
• Review and approve Rework Protocols for packaging operations.
- Proficient use of MS Office, including Word and Excel
- Knowledge of Good Manufacturing Practices, Food and Drug Administration (FDA) regulations (FDA 21 CFR – Part 111,114 and 117) and documentation procedures.
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