MARCUS SHELBY
Quality Assurance
Irvine,CA
Summary
Quality Management professional with successful career delivering efficiency and standardization, and maintaining all ISO and QS 9000 and Quality Systems. Drives smooth operation of production and manufacturing lines, coordinate efforts of employees and facilitate communication between management and production departments. Apply creativity in improving manufacturing process to achieve higher productivity and quality of finished goods. Experience in reviewing and interpreting regulatory and programmatic guidance, implementation of corporate compliance, risk management and corrective action programs.
Overview
20
20
years of professional experience
Work History
Quality Manager
Breathe Technologies/Hillrom
Irvine, CA
02.2019 - 10.2021
- Manage Document Control and Incoming Inspection (IQC)
- Manage Calibration and Preventive Maintenance
- Manage and maintain Complaints, CAPA's and Deviations
- Manage and maintain Internal Quality Audits
- Managed and conducted Management Reviews
- Support/Lead external regulatory audits
- Maintain External Regulatory Standards library
- Administered ManufactPro (MRP)
- Created metrics for Management Review and quarterly Quality updates.
- Updated quality control standards, methods and procedures to meet compliance requirements.
- Liaised with HR manager to organize and perform quality standard training for new and existing staff.
- Developed and deployed production control plans and created work instructions and procedures.
- Sorted product and provided expertise on non-conforming product requirements.
- Managed and archived quality documentation and participated in internal and external quality audits.
- Improved quality processes for increased efficiency and effectiveness.
- Wrote and implemented new rework procedures to standardize processes and streamline workflow.
- Evaluated quality problems and performed assessments to identify and resolve issues.
- Mentored and encouraged employees to strive for excellence while fostering professional growth.
- Collaborated with contract representatives and oversaw quality control implementations and reporting.
Quality Consultant
Self Employment Specialists
Irvine, CA
05.2018 - 02.2019
- Conducted Supplier Audits
- Conducted Internal Quality Audits
- Assisted with remediation to prepare for external audits
- Updated and created SOP, Work Instructions, and Quality Instructions
- Manage Calibration Program
- Support external regulatory audits
- Maintain External Regulatory Standards library
- Created metrics for Management Review
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
Director Quality Compliance
Pulmostics Limited
Thousand Oaks, CA
11.2016 - 05.2018
- Created/maintain Quality Management System
- Quality Management System training and maintain records
- Manage and maintain Approved Supplier List (ASL)
- Manage Calibration Program
- Managed Internal Quality Audits
- Managed Supplier Audits
- Maintain Device Master Record (DMR)
- Maintain External Regulatory Standards library
- Developed and implemented internal control tests to verify employee compliance with established policies and procedures.
Sr. Quality Assurance Specialist
Breathe Technologies
Irvine, CA
04.2009 - 11.2016
- Managed change control process
- Updated and created SOP, Work Instructions, and Quality Instructions
- Coordinated and managed Sterilization process
- Coordinated NCMR, CAPA
- And complaints processes
- Managed Document Control
- Final Lot History Record (LHR) review
- Managed training and maintain records
- Manage and maintain Approved Supplier List (ASL)
- Manage Calibration Program
- Coordinated and conduct Internal Quality Audits
- Coordinated and conducted Supplier Audits
- Maintain Device Master Record (DMR)
- Support external regulatory audits
- Maintain External Regulatory Standards library
- Admin and assisted with implantation of MRP system (ManufactPro)
- Assisted with implementation of Materials and Shipping/receiving processes
- Created metrics for Management Review and quarterly Quality updates.
- Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Halted production line in case of major non-compliance of specifications, standards or quality discovered during inspection process.
- Developed monthly, end-of-quarter and other statistical reports for leadership team and quality improvement programs.
- Monitored product standards and quality-control programs.
- Created and collaborated in implementation and maintenance of customer complaint log, control plans, work and inspection instructions, local procedures and visual aids and samples.
Quality Assurance Associate
Pulmonx, Inc
Palo Alto, CA
07.2007 - 11.2008
- Managed the change control process
- Coordinate/assisted Internal Audit, NCMR, and CAPA processes
- Final Device History Record (DHR) Review
- Managed training and maintain records
- Managed and maintain Approved Supplier List (ASL)
- Managed Calibration Program
- Conduct Internal Quality Audits
- Maintain Device Master Record (DMR)
- Maintain External Regulatory Standards library
- Reviewed and implemented Engineering Change Orders (ECO)
- Coordinated CAPA process
- Managed calibration process
- Supported audit preparation through research, analysis and presentation development.
- Assisted with independent internal and external audits.
Document Control Specialist/QA Specialist
HAYES MEDICAL, INC
El Dorado Hills, CA
06.2006 - 06.2007
- Managed and conducted Internal Quality Audits
- Conducted product audits and final DHR reviews
- Managed Access Databases and maintained all related QMS documentation.
- Maintained Electronic records, Master Files, and staged documents during external audits (ISO/CE)
- Updated and created drawings using Corel Draw, Solid Works, AutoCad and controlled firmware files.
- Assisted in continuous improvement activities while developing and maintaining resulting documents.
- Maintained document control system and updated work instructions, procedures and associated databases.
- Oversaw creation, routing and data input of bills of materials, ECOs, ECRs and ISO documents.
Document Specialist
GENENTECH
Vacaville, CA
03.2005 - 04.2006
- Provided engineering support for building additions to the plant
- Re-organized and enhanced existing Document Control processes
- Maintained database for company metrics
Document Control Specialist
JOMED/VOLCANO THERAPUETICS
Rancho Cordova, CA
03.2001 - 03.2005
- Created, Routed, and Implemented ECO, MCO, and Deviations using Agile
- Trained new user on Agile
- Conducted internal Quality Audits per ISO 13485:2003, ISO 9001:2000 & CFR part 820 QSR
- Responsible for maintaining all documentation including SOP’s, Drawings, Item Master, ECO
- Issued and conducted maintenance of Controlled Documentation
- Assisted during external regulatory audits
- Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.
- Released and updated drawings and specifications.
- Oversaw creation, routing and data input of bills of materials, ECOs, ECRs and ISO documents.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Skills
Quality processes
undefinedTimeline
Quality Manager
Breathe Technologies/Hillrom
02.2019 - 10.2021
Quality Consultant
Self Employment Specialists
05.2018 - 02.2019
Director Quality Compliance
Pulmostics Limited
11.2016 - 05.2018
Sr. Quality Assurance Specialist
Breathe Technologies
04.2009 - 11.2016
Quality Assurance Associate
Pulmonx, Inc
07.2007 - 11.2008
Document Control Specialist/QA Specialist
HAYES MEDICAL, INC
06.2006 - 06.2007
Document Specialist
GENENTECH
03.2005 - 04.2006
Document Control Specialist
JOMED/VOLCANO THERAPUETICS
03.2001 - 03.2005
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