Manager, Quality & Training Resume
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TECHNICAL SKILLS
- Quality Assurance
- Safety Compliance
- Quality Assurance Management
- Regulatory Compliance
- Continuous Improvement
- Scrum Fundamentals Certified (SFC)
- Six Sigma Yellow Belt
PROFESSIONAL EXPERIENCE
Manager, Quality & Training
Confidential
Responsibilities:
- Implemented the quality management system within two facilities
- Lead a team of Supervisors, QA auditors and analysts
- Conduct internal and third - party audits
- Assist operations to ensure compliance and process adherence
- Implemented periodic review and updates to SOPs and work instructions within two facilities
- Develop and drive continuous improvement initiatives
- Train associates with focus on processes, cGMP, FDA, and ISO regulations
- Investigate customer escalations to determine root cause and determine corrective action
- Ensure quality standards are withheld through internal sample audits
- Monitor KPIs and drive corrective action for areas with most frequent findings
QA & EHS Manager
Confidential
Responsibilities:
- Led team of 10 QC Auditors
- Accountable for adding and releasing medical devices in Quarantine status
- Led team of 10 Safety Team members
- Accountable for cold chain verification upon receipt
- Coordination of product returns and destruction
- Daily log of temperature and environmental monitoring
- Conducted annual Safety and TSA training
- External audits with clients, vendors, FDA, and DEA
Lead QA Auditor / Technicolor
Confidential
Responsibilities:
- Coordinated daily activities
- Performed visual, mechanical and operational audits
- Daily reporting of testing results to Microsoft Software Development Team
- Developed flowcharts for QA processes performed
- Created and updated departmental work instructions
- Distributed QA metric reporting
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