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 • 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 compliance with FDA regulations, ISO standards, EU MDR and any other international regulations and internal requirements.• Apply sound, systematic, problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.• Operate with a high level of autonomy and responsibility • Recognize, analyze and implement opportunities for cross-business collaboration and process improvements.• Lead business process improvement projects that require a high level of technical/process analysis skills for the quality department• Establish clear targets and design concepts for projects and drive change management as required• Role model for others within QA and the broader business. Show less

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. Managed Product Change Notification (PCN) process. • 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… Show more • 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. Managed Product Change Notification (PCN) process. • 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 CAPAsSO 14001:2015 implementation core team member. Charged with reviewing, modifying and approving Environmental, Health and Safety (EHS) documentation compliant to the ISO standards, key contributor to risk assessments process: set/track Targets and Objectives. • 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 groundwater monitoring and remediation: Bio-remediation Pilot Test. Maintained remediation financials and interfaced with remediation site(s) property owners, company contractors, inside and outside council, and Water Board case workers. • 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 in progress, WF process errors, various WF performance monitors, and SLA performance metrics. • Agile Product Governance and Compliance (PGC) module Admin and Compliance Manager; Authored corporate customer-facing material composition and compliance declarations. Compiled and released 3rd-party analytical and MSDS/SDS product reports to customers. Show less

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 compliance data. Oversaw company import / export processes and documentation. • 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 • 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 compliance data. Oversaw company import / export processes and documentation. • 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 remediation financials and interfaced with remediation site(s) property owners, company contractors, inside and outside council, and Water Board case workers, GeoTracker uploads.• 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 and coordinated offshore EHS representative assignments. • 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 articles (Employee Communications.) Managed CAPA process.• 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. • Created and maintained EHS documentation compliant to the ISO standards. Managed risk assessments process: set/track Targets and Objectives. Managed company processes and documentation to ensure certification to ISO 14001:2008 and compliance to the EICC Code of Conduct (includes compliant with OHSAS 18001, SA8000.)• Developed company training presentations for ISO 9001 / 14001, export/import, SharePoint site creation and management, environmental remediation, health and safety, Agile Product Governance and Compliance module, Product Environmental Compliance, etc. Show less

Newport Beach

Greater San Diego Area

Calibration and repair of company test equipment.