Hi, I’m
Frederick Mond
Senior Quality Assurance Consultant
Augusta,GA
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Summary
Precise Senior Quality Assurance Consultant with over sixteen years of experience in ensuring the quality of medical device manufacturing and overseeing manufacturing quality management systems while responsible for reviewing and analyzing existing quality control processes, identifying areas for improvement, and developing strategies to enhance overall quality standards. Adept in providing guidance and support to junior team members, troubleshooting technical issues, and conducting thorough testing to identify and resolve defects in products or services. Maintained high-quality standards and ensured customer satisfaction, resulting in a 50% reduction in defects and a 25% increase in production efficiency.
Overview
16
years of professional experience
9
Years served in the U.S. Army
Work History
ILC Dover-Frederica
Quality Contractor
9 2023 - Current
Job overview
- Investigate non-conformances and consumer complaints, lead completion of root cause analysis, implement corrective actions, and monitor progress and improvements
- Establish, define, implement, maintain, and report on quality assurance key performance measures and standards
- Develop CAPA Strategies for the investigation and prevention of systemic failures
- Drive continuous improvement on quality standards, requirements, and best practices
- Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions
- Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
- Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
- Prepares and presents technical and program information to team members and management.
- Enhanced team productivity by providing ongoing training and support to junior staff members.
- Conducted risk assessments to minimize potential quality issues, ensuring product safety and compliance with industry regulations.
Olympus-Veran
QA Consultant
03.2022 - 05.2023
Job overview
- Providing support to client’s QMS needs in Corrective and Preventive Action (CAPA) programs in the medical device industry
- Conducted CAPA investigations, root cause analysis, and planning to prevent identified root causes
- Communicated with client’s management teams on progress of CAPA projects to meet their internal and regulatory requirements.
JABIL Health/JNJ
QA Consultant
09.2022 - 11.2022
Job overview
- Conducted CAPA investigations, root cause analysis, and planning to prevent identified root causes
- Keep projects on track to timely completion, reporting directly to the client’s management teams.
Johnson&Johnson
QA Consultant
01.2022 - 03.2022
Job overview
- CAPA Lead for Swivel Hand Piece, Gap Analysis of manufacturing work instructions
- Technical Review Team (SHP)
- Review and update (SHP) procedures and work instructions.
Network Partners BD
QA Consultant
01.2021 - 01.2022
Job overview
- Conducted CAPA investigations, root cause analysis, and planning to prevent identified root causes
- Communicated with client’s management teams on progress of CAPA projects to meet their internal and regulatory requirements.
MW Life Sciences-Paragon Medical
QA Consultant
12.2020 - 03.2021
Job overview
- CAPA (SME), Non-Conformance Investigations, Root Cause Analysis
- Coach engineers on NCR regulatory requirements CFR820.90 and linkage with CFR820.100
- Escalate NCRs to CAPAs based on risk, severity, occurrence, and trending
- Coach and mentor engineers on CAPA investigations and root cause analysis.
Johnson&Johnson (Sterilmed)
QA Consultant
10.2018 - 02.2020
Job overview
- CAPA Remediation Team/CAPA-NC Site Lead
- Lead CAPA teams as a subject matter expert to the CAPA system
- Keep projects on track to timely completion, reporting directly to the client’s management teams.
Medtronic/Cardinal Health
Quality Compliance Coordinator
01.2015 - 10.2018
Job overview
- Managed CAPA System and Quality Control Teams for the manufacturing site
- Worked with site Quality Leader to manage audits, maintain the Quality Management System, and perform continuous improvement activities
- Acted as an expert in CAPA and Validation/Verification planning
- Maintained the Quality Management System at the site through training, continuous improvement, and production controls
- Supported FDA, ISO 13485, and customer audits while performing supplier quality audits
- Lead CAPA review board and non-conformance trending
- Established and maintained cGMP practices in site operations
- Implement updates to Quality Management System (QMS) to meet ISO 9001:2015, ISO 13485:2016, FDA, and Medical Device Single Audit Program (MDSAP) regulations.
Education
University of Texas At San Antonio San Antonio, TX
Associate of Science from Health Sciences
05.2001
Academy of Health Sciences San Antonio, TX
from Health Sciences
05.2001
U. S. Army Medical Department Center And SchoolSan Antonio, TX
from Health Sciences
05.2001
Skills
Quality Assurance
Project Management
ISO 9001/13485
Technical Writing
Document Control
CAPA SME
Root Cause Analysis
FDA 483 Warning Letter
Consent Decree remediation
Non-conformance Escalation
Complaints/Reporting
MDSAP Trained Assessor
21CFR820
Risk Management
Current good manufacturing practices (cGMP)
Agile
Regression Testing Expertise
Test case design
Load and stress testing
User Acceptance Testing
Current Good Documentation Practices (cGDP)
Quality Management System (QMS)
Quality System Regulation (QSR)
Trackwise
Windchill (product lifecycle management software)
Affiliations
Proud participant in The Augusta Warrior Project, a community of veterans supporting fellow veterans
Military Experience
Nine-Year Military Veteran from the U.S. Army
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
swipe to browse