Sayfon Inthisane
Cape Coral
Summary
Quality Systems Auditor with a strong focus on regulatory compliance and process improvement. Experienced in auditing, risk assessments, and maintaining SOP and cGMP standards. Proven track record of enhancing quality systems and facilitating effective collaboration across teams.
Overview
21
21
years of professional experience
Work History
Quality Systems Auditor
KDC-One
Groveport
11.2022 - Current
- Conduct risk assessments and review design control documentation to ensure compliance with regulatory standards.
- Audit manufacturing records, SOPs, Work Instructions, and cGMP processes to ensure customer and company compliance.
- Maintained accurate audit documentation and prepared Risk Management Reports, effectively communicating findings with cross-functional teams.
- Supported continuous improvement initiatives, enhancing organizational quality systems and processes.
Quality Assurance Inspector
Hughes Circuits
San Marcos
05.2018 - 10.2022
- Executed first article inspections and routine quality checks to ensure product quality standards were met throughout production.
- Facilitated CAPA investigations and resolved non-conformance issues, ensuring effective communication with production teams.
- Assessed production documentation for accuracy, completeness, and compliance to uphold regulatory requirements.
Production Supervisor
Somacis Inc.
Poway
04.2005 - 04.2018
- Supervised production teams and coordinated workflow to meet production deadlines consistently.
- Resolved product quality, equipment, safety, and employee-relations issues, enhancing customer service in a fast-paced environment.
- Supported SPC, preventive maintenance, audits, ISO 9001 compliance, and 5S initiatives.
Education
GED -
San Diego Adult School
San Diego, CASkills
- Quality Auditing & Compliance
- SOP & cGMP Compliance
- ISO Compliance
- Regulatory compliance
- Internal Auditing
- CAPA Processes
- CAPA management
- Risk Assessment
- Quality control
- Process improvement
- Continuous improvement
- ISO 9001 Standards
- Office software proficiency
- Problem solving
- Leadership & Team Collaboration
- Documentation management
Timeline
Quality Systems Auditor
KDC-One
11.2022 - Current
Quality Assurance Inspector
Hughes Circuits
05.2018 - 10.2022
Production Supervisor
Somacis Inc.
04.2005 - 04.2018
GED -
San Diego Adult School