LeShawn Dimery
Charlotte,NC
Summary
Quality Management professional with a successful career delivering efficiency and standardization and maintaining all ISO standards and Quality Systems.
Manage quality audit program to identify and resolve non-conformities and embed a culture of continuous improvement. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
18
18
years of professional experience
Work History
Quality Assurance Program Manager
OneBlood
09.2019 - Current
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
- Established and tracked quality department goals and objectives.
- Assessed product quality by monitoring quality assurance metrics, reports, and dashboards.
- Conducted risk assessments to identify and mitigate potential quality issues.
- Created and maintained quality management systems to align with industry standards.
- Recorded, analyzed, and distributed statistical information.
Senior Engineer – Product Safety
Lowes Home Improvement Corporate Headquarters
07.2018 - 09.2019
- Investigated causes of accidents, injuries, or illnesses and develop a solution to minimize or prevent a recurrence.
- Developed, implemented, and managed the product safety program
- Adhered to timelines to meet quality assurance targets.
- Determined project specifications by thoroughly studying performance standards, requirements, and technical studies.
- Collaborated with other departments to facilitate successful project completion.
- Created detailed reports on engineering activities and findings.
- Performed complex calculations to analyze and optimize engineering processes.
Quality Assurance Manager
Prodigy Diabetes Care LLC
02.2016 - 04.2018
- Maintained and improved the Quality Management System (QMS) to ensure compliance with ISO standards and QSR regulations and achieved continuous improvement.
- Conducted training sessions to educate staff on QMS principles
- Developed and maintained quality metrics and key performance indicators to measure and report on the effectiveness of quality systems
- Ensured the timely investigation and resolution of customer complaints about product quality.
- Process Medical Device reporting according to FDA Regulations.
- Tracked quality issues with external customers and suppliers.
- Scheduled and chaired quality review meetings to review performance effectiveness, mitigate risk, and achieve customer satisfaction.
- Conducted regular internal audits to assess compliance.
Senior QA Consultant (Contract – ConvaTec Ostomy and Wound Care)
Regulatory and Quality Solutions
08.2014 - 02.2016
- Managed various QMS systems components – CAPAs, Deviation, Quality Investigations, and Product Complaints while maintaining QSR regulations and GMP Manufacturing practices for Ostomy, Wound, and Skincare and continence products
- Managed the Trackwise CAPA system by analyzing its effectiveness and identifying trends
- Developed and recommended corrective actions to prevent recurrence by collaborating with cross-functional teams
- Analyzed complaints and adverse events to determine if an investigation was required and distinguished if there was a malfunction, severe injury, or death and whether the complaint was complete and accurate to indicate potential safety issues
- Managed investigation results for resolutions and root cause analysis with the product manufacturers and production staff.
Senior Post Market Surveillance Consultant (Contract - Fresenius Kabi Medical Care Headquarters)
Validant Consulting LLC
10.2013 - 06.2014
- Responsible for the day-to-day oversight of the Post Market Surveillance department to achieve mutual goals, assigned tasks, and maintained schedules with an understanding of 21 CFR 820 and 21 CFR 211
- Generated MDR / Vigilance reports and submitted them to the applicable authorities
- Reviewed, received, and evaluated product complaints about manufactured and distributed products (equipment, drugs, and devices) utilizing TrackWise.
- Developed, executed, and managed the CAPA Management system
- Worked closely with Management to establish weekly quality performance
- Analyzed quality data to identify trends and ways to manage them appropriately.
Senior QA Consultant (Contract - Johnson & Johnson: Depuy Synthes)
Maetrics LLC
03.2013 - 10.2013
- Reviewed and approved site SOPs, non-conformance reports, and CAPAs
- Provided Consulting Services related to ISO 13485 standards in conjunction with the applicable Code of Federal Regulations
- Provided direct support for adverse events, medical device reportable events, and product recall activities, including corrections and removals
- Participated in internal and external Audits.
- Collected and analyzed data to measure effectiveness of quality control processes.
Senior Compliance Consultant (Contract - Pfizer)
Propharma Group
05.2012 - 03.2013
- Provided consultant services in Pharmaceuticals and medical devices to conduct evaluations by following GMP – ISO regulations.
- Implemented process improvements focusing on quality processes to manage CAPAs and training. Reviewed and approved CAPA records in TrackWise.
- Performed manufacturing record reviews for deficiencies and provided suggestions for improvements.
- Assisted with internal and external audits to confirm compliance with applicable laws and regulations.
- Reviewed, revised, and updated compliance policies and procedures to confirm continual compliance with applicable laws.
- Investigated and documented all violations of compliance regulations to determine necessary improvements.
Quality Systems Supervisor
Grifols Plasma Resources
12.2009 - 05.2012
- Oversight of all aspects of internal and external audits, including execution
- Monitored processes and ensured center compliance with state, federal, and company-designated regulations
- Collaborated with Center Managers to ensure product quality, donor suitability, and donor safety
- Continuously assessed and improved the effectiveness of the quality systems in the donor center through the recognition of trends, investigation of failures in the execution of procedures, direct employee observation, and review of center documents
- Performed lookback activities, donor deferral, and reinstatement.
- Mentored employees and offered constructive feedback for performance improvement.
Lead Laboratory Technologist Infectious Disease
American Red Cross-National Testing Laboratories
03.2006 - 12.2009
- Managed daily laboratory operations, inventory management, supervision and staff scheduling, and maintenance of equipment and supplies.
- Managed a team of 25 technicians, completed training, competencies, and education services, and provided feedback.
- Reviewed and analyzed test results, identified trends, developed and implemented quality control measures, and provided recommendations for process improvement
- Participated in internal and external audits
- Adhered to laboratory safety procedures to maintain compliance with regulatory standards.
- Kept abreast of current industry, scientific and regulatory developments and issues.
Education
Bachelor of Science - Biology -
Johnson C Smith University
Bachelor of Science – Occupational Safety and Health -
North Carolina A & T University
Master of Social Work -
Winthrop University
Skills
- Documentation Review
- Problem Solving
- Process Improvement
- Quality Control
- Regulatory Compliance
- Project Management
- ISO Standards
- Data Analysis
- Internal Audits
- Complaint Investigation
- QMS
- Risk Assessment
Timeline
Quality Assurance Program Manager
OneBlood
09.2019 - Current
Senior Engineer – Product Safety
Lowes Home Improvement Corporate Headquarters
07.2018 - 09.2019
Quality Assurance Manager
Prodigy Diabetes Care LLC
02.2016 - 04.2018
Senior QA Consultant (Contract – ConvaTec Ostomy and Wound Care)
Regulatory and Quality Solutions
08.2014 - 02.2016
Senior Post Market Surveillance Consultant (Contract - Fresenius Kabi Medical Care Headquarters)
Validant Consulting LLC
10.2013 - 06.2014
Senior QA Consultant (Contract - Johnson & Johnson: Depuy Synthes)
Maetrics LLC
03.2013 - 10.2013
Senior Compliance Consultant (Contract - Pfizer)
Propharma Group
05.2012 - 03.2013
Quality Systems Supervisor
Grifols Plasma Resources
12.2009 - 05.2012
Lead Laboratory Technologist Infectious Disease
American Red Cross-National Testing Laboratories
03.2006 - 12.2009
Bachelor of Science - Biology -
Johnson C Smith University
Bachelor of Science – Occupational Safety and Health -
North Carolina A & T University
Master of Social Work -
Winthrop University
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