Sr. Quality Asurrance Engineer

Sr. Quality Assurance Engineer leads quality initiatives, develops test methods, and ensures compliance with ISO/FDA standards. Drives root cause analysis, CAPA, and continuous improvement in manufacturing processes.
Supports new product introductions and validation at all levels.

• Develops methods and metrics for Key Quality Indicators.
• Analyzes data and distributes reports to internal departments and BD divisions.
• Leads quality documentation, records management, and electronic data control.
• Drives training and awareness in quality procedures.
• Leads root cause analysis and CAPA (Corrective and Preventive Actions).
• Implements continuous improvement programs to reduce defects and risks.
• Participates in test method development, new product development, complaint handling, and change control.
• Supports compliance with ISO, FDA, and corporate standards.
• Leads quality aspects of new product introductions.

• Provides technical guidance to QA Engineers/Technicians.
• Participates in A3 creation for Quality.
• Applies intermediate statistical methods (e.g., regression, ANOVA).
• Manages non-conforming product disposition and MRB actions.
• Designs quality studies and reports.
• Approves/supports validation protocols (IQ/OQ/PQ).
• Acts as SME for process/test method validations.
• Leads CAPA assessments and improvements.
• Develops sampling plans and understands OC curves.
• Handles customer complaint evaluations.
• Leads Nonconformance (NC) processes.
• Develops Control Plans and Test Methods.
• Acts as Initial Impact Assessment (IIA) Approver in PegaSystems Change Control.

• Familiarity with ISO 13485, FDA regulations.
• Certified Quality Engineer (preferred).
• Proficient in quality tools and statistical techniques.
• Experience in root cause analysis, test method development, and process validation.
• Strong English communication skills (oral and written).
• Leadership and team supervision experience.

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