CONRAD P. ROBLEJO
LAUDERHILL,FL
Summary
Accomplished, quality professional with dedication to the development of high-quality products and processes, with the following broad-based competencies
Overview
28
28
years of professional experience
Work History
SENIOR SPECIALIST, REGULATORY AFFAIRS
INTERNATIONAL MEDICAL INDUSTRIES
01.2023 - 01.2024
- Operate at the QA/RA staff level to execute and assure that all Regulatory licenses, registrations, certifications, and submissions are made on time with appropriate content and funding
- Provides “lead and direct” oversight of contract Regulatory Affairs consultants
- Defined the Regulatory Affairs Quality System by authoring documents including System Procedures, Work Instructions and Forms
- Provide expert RA input to requests regarding new markets or new regulatory requirements
- Complete and submit Regulatory Submission documents such as US FDA 510(k)s and EU Technical Files, work with reviewing bodies to complete the approval process resulting in opening the targeted market
QUALITY ASSURANCE MANAGER
INTERNATIONAL MEDICAL INDUSTRIES
01.2018 - 01.2023
- Rebuilt the entire Quality Management System
- Responsible for the direct management of QA/QC supervisors and technicians
- Allocates resources based upon departmental plans & budgets
- Responsible for hire/fire decisions within their department
- Submits departmental budgets, performance / productivity targets and reports on results
- Measured against performance plan goals and objectives
- Responsible for departmental performance
- Designated back-up as Management Representative
- Experience with all phases of the product development lifecycle, including concept, design, implementation, verification, and validation activities necessary for product commercialization in a medical device environment
- Extensive experience in GMP and other Regulatory compliance requirements
- Developed and trained cGMP/GDP to FDA-oversight companies
- Provide direct oversight of non-conformances, manage the NCP database, and provide guidance for resolution of non-conformances
- Chair the regular occurring Management Review Board Meetings
QC SUPERVISOR - PACKAGING & FINAL RELEASE
BOLTON MEDICAL (TERUMO AORTIC)
01.2017 - 01.2018
- Responsible for supporting the Quality Operations of in-process and finished product and maintaining processes and methods in accordance with the company standards
- Reporting on the performance of the assigned Quality areas
- Management of QA/QC staff, GMP and ISO compliance
- Identify, report, and monitor non-conforming events for the Final Packaging and Release areas
- Perform product failure investigations and implement corrective and preventive actions to prevent reoccurrence
- Interact with cross-functional teams to resolve quality issues
- Develop Quality Instructions and Quality Standards
- Provide support in the development, validation, and implementation of test methods
- Create, review, and approve engineering changes to support product life cycle
- Support the Corrective and Preventive Action system (CAPA)
- Establish Quality Assurance objectives and assignments and delegate assignments to subordinates
- Identify and evaluate fundamental compliance issues for major functional areas through assessment of Quality system compliance
SOFTWARE QUALITY MANAGER/HELP DESK MANAGER
MEDICFP, LLC.
01.2015 - 01.2017
- Implement and maintain Customer Help Desk / Quality Management System for MedicFP Customer Service organization responsible for all global consumer contacts and all MedicFP Software products
- Oversee timely delivery of quality technical support services to clients
- Ensure that staffing and skill levels are maintained throughout operational hours by managing shift staffing schedules
- Responsible for all quality metrics as it relates to the Help Desk
- Responsible for all Help Desk documentation
- Acting as an escalation point when challenging issues arise
- Report to Senior Management on any issues that could significantly impact the business
- Working with Product Development in developing Software Test Plans for entire MedicFP suite of software solutions
- Creating/reviewing documentation for MedicFP Pilot programs (i.e., Service Level Agreements, MedicFP Disaster Recovery/Business Continuity Plan, User Guides, Software Test Plans, Risk Assessments, Process Flows and Frequently Asked Questions)
Senior Quality Systems Assessment Specialist / SQE/ Lead Auditor
Beckman Coulter, INC
01.2009 - 01.2011
- Conduct Quality System, Internal, Supplier and Process audits as scheduled using risk-based approach
- Develop and implement supplier improvement strategies using SCAR’s and FMEA’s
- Drive supplier corrective action programs as required
- Collaborate with Product Development and Technical Operations on Design of Experiments (DOE’s) to facilitate the introduction of new products and processes
- Manage supplier selection and approvals
- Responsible for proper management and disposition of all nonconforming material for all commodities, with the exception of plastics and metals
- Coordinate risk assessments for suppliers as well as for raw material issues
- Effectively provide quality support for project teams focused on OEM on-boarding
QUALITY SYSTEMS MANAGER
MOTOROLA, INC
01.1996 - 01.2008
- Implement and maintain Quality Management System for Motorola’s Customer Service organization responsible for all global consumer contacts and all Motorola Mobile Device products
- Participated in key Six Sigma projects for the Customer Care organization
- Projects included reduction of AHT and establishing KPI’s at Motorola outsourced call centers in the U.S
- And Latin America
- Responsibility extended to Customer Satisfaction for Latin America and South Asia as well as other markets as needed to successfully meet corporate goals
Education
Bachelor of Science Degree - Business Management
Nova Southeastern University
Fort Lauderdale, Florida01.2004
Master’s Certificate - Project Management
George Washington School of Business and Public Management
Washington, D.C.01.2002
Failure Mode and (Potential) Effects Analysis (FMEA, 8-D Problem Solving Skills, Six Sigma Green Belt
Motorola University
PlantationSkills
- ISO 13485
- 21 CFR Part 820
- EU MDR
- Host FDA site inspections
- Registrar Audits
- CA/PA
- Complaint response
- Class II Device Design
- Class III Device Design
- Product Design
- Verification
- Validation
- EU Technical Documentation Submissions
- Sterile Manufacturing
- Packaging
- Terminal Sterilization
- 510(k) applications
- Lean Manufacturing
- Six Sigma Black Belt
Educationandprofessionaltraining
- Nova Southeastern University, Fort Lauderdale, FL, Bachelor of Science Degree in Business Management, 2004
- George Washington School of Business and Public Management, Washington, D.C., Master’s Certificate in Project Management, 2002
- Motorola University, Failure Mode and (Potential) Effects Analysis (FMEA), 8-D Problem Solving Skills, Six Sigma Green Belt, RABQSA certified QMS Lead Auditor, IRCA certified QMS Senior Auditor
Timeline
SENIOR SPECIALIST, REGULATORY AFFAIRS
INTERNATIONAL MEDICAL INDUSTRIES
01.2023 - 01.2024
QUALITY ASSURANCE MANAGER
INTERNATIONAL MEDICAL INDUSTRIES
01.2018 - 01.2023
QC SUPERVISOR - PACKAGING & FINAL RELEASE
BOLTON MEDICAL (TERUMO AORTIC)
01.2017 - 01.2018
SOFTWARE QUALITY MANAGER/HELP DESK MANAGER
MEDICFP, LLC.
01.2015 - 01.2017
Senior Quality Systems Assessment Specialist / SQE/ Lead Auditor
Beckman Coulter, INC
01.2009 - 01.2011
QUALITY SYSTEMS MANAGER
MOTOROLA, INC
01.1996 - 01.2008
Bachelor of Science Degree - Business Management
Nova Southeastern University
Master’s Certificate - Project Management
George Washington School of Business and Public Management
Failure Mode and (Potential) Effects Analysis (FMEA, 8-D Problem Solving Skills, Six Sigma Green Belt
Motorola University
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