Tom Krawczyk Email & Phone Number

San Diego, California, United States

Greater San Diego Area

• Certified ISO 13485 Lead Auditor
• Drive and Lead Major CAPA’s and ensure the CAPA process and all CAPA investigations and reports meet the requirements of the business and external authorities.
• Maintain quality systems and supporting procedures to ensure that ResMed quality systems comply with the requirements and intent of the applicable regulatory standards.
• Conduct and participate in internal and external Quality System audits and regulatory inspections to assess the… Show more
• Conduct and participate in internal and external Quality System audits and regulatory inspections to assess the compliance with FDA regulations, ISO standards, EU MDR and any other international regulations and.
• Apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.

San Jose

• Quality lead for Conexant and Synaptics integration project. Supplier/Customer interface for QMS/EMS surveys and product environmental compliance data. Oversaw company import / export processes and documentation..
• Led company as Program Manager and internal auditor to pass IoT business 1st ISO 9001:2015 full certification audit with no findings. Authored and maintained ISO 9001 process documentation. Identify, track and close….
• Led company as Program Manager and internal auditor to pass IoT business 1st ISO 9001:2015 full certification audit with no findings. Authored and maintained ISO 9001 process documentation. Identify, track and close.
• Perform Quarterly process and documentation EHS audits – ensured compliance to local/regional/national EHS rules/regulations. Managed IoT business Hazardous and Universal Waste collection, storage and disposal.
• Managed Chlorinated Solvent groundwater remediation project reportable to the Regional Water Quality Control Board – Santa Ana (RWQCB-SA). Ensured compliance with Water Board remediation mandates. Activities include.
• Awarded Automotive SPICE Level II for SUP 9 Problem Resolution Management process. Created and documented problem resolution management process workflow (WF) in JIRA. Created JIRA dashboards and filters tracking work.

Irvine CA

• Developed and Maintained documentation and processes for ISO 9001:2008 Quality Management and ISO 14001:2008 Environmental Management systems. Supplier/Customer interface for QMS/EMS surveys and product environmental.
• Managed Chlorinated Solvent soil and groundwater remediation project reportable to the Regional Water Quality Control Board – Santa Ana (RWQCB-SA). Ensured compliance with Water Board remediation… Show more
• Managed Chlorinated Solvent soil and groundwater remediation project reportable to the Regional Water Quality Control Board – Santa Ana (RWQCB-SA). Ensured compliance with Water Board remediation mandates. Maintained.
• Created and maintained EHS documentation compliant to ISO standards. Performed quarterly EHS audits – ensured compliance to local/regional/national EHS rules/regulations. Developed employee EHS training presentations.
• Managed Hazardous and Universal Waste collection, storage and disposal. Oversaw internal process and documentation audits for ISO 14001 perform Quarterly EHS Audits. Developed and published EHS topic newsletter.
• Led company to pass 2 full re-assessment and 5 periodic audits to ISO 9001 / ISO 14001 with no findings. Owned Document Control System/Site in SharePoint.

Newport Beach

Greater San Diego Area

Calibration and repair of company test equipment.