Bob Pendleton Email & Phone Number

Jupiter, Florida, US

• I was a part of a team working to incorporate a Medical Device into an ISO 13485 Quality System. My responsibilities included:
• Creating Quality System Documents, Work Instructions, Forms, Records and Templates
• Supplier Audits
• Nonconformances
• Corrective & Preventive Actions
• Change Control

Wilmington, MA, US

• I was a part of a validation team working to incorporate newly manufactured components into an ISO 13485 Quality System. My responsibilities included:
• Process Verifications
• Process Validations
• Design of Experiments
• Creating Protocols & Test Reports
• Performing Test Method Validations

Auburn, Alabama, US

• I was part of the Quality Group that had the following responsibilities:
• Process Validation Protocols
• Internal Auditing.
• Inspection Plans.
• Change Control
• Writing Procedures & Work Instructions

Beverly, Massachusetts, US

• I was part of the Design Group at Freudenberg Medical working on projects for Medtronic and Boston Scientific. My responsibilities included:
• Design Reviews
• Deviation Reports
• Verification and Validation
• Protocol Writing
• Technical Report Writing.

New York, New York, US

• Remediation effort associated with FDA 483 Warning Letter concerning supplier quality agreements of combination products. Responsibilities include:
• Performing review and gap analysis of existing quality agreements to QSR requirements.
• Creating amendments to quality agreements.
• Facilitation of amendments with applicable Pfizer organization and affected suppliers.
• Updated internal systems upon approval.

• Review and update Quality Management System to comply with QSR and ISO 13485. Activities include:
• Preform gap analysis of Supplier Management System
• Review existing procedures/work instructions for compliance to QSR and ISO 13485
• Create Audit Schedule
• Audit Critical Suppliers
• Manage Supplier SCAR System

Amsterdam, Noord-Holland, NL

• Creation of Supplier Inspection Plans.
• Facilitated Interplant Product Transfers with appropriate Inspections & documentation.
• Verified & Validated New Product Designs.
• Performed Statistical Analysis & Generated Technical Reports

Amsterdam, Noord-Holland, NL

• This was a Start-Up, Class III Pharmaceutical/Biologics company. My responsibilities included:
• Performed Gap Analysis of QMS for Regulatory Compliance.
• Wrote Procedures & Work Instructions.
• Process Mapping of Drug Operations to identify Inherent Risks.
• Facilitated dFMEA & pFMEA Activities.
• Created Critical Parts Lists.

• This was a Start-Up, Class III Pharmaceutical/Biologics company. My responsibilities included:
• Performed Gap Analysis of QMS for Regulatory Compliance.
• Wrote Procedures & Work Instructions.
• Process Mapping of Drug Operations to identify Inherent Risks.
• Facilitated dFMEA & pFMEA Activities.
• Created Critical Parts Lists.

• I was part of the Quality Assurance Group involved with the creation and execution of IQ/OQ/PQ CMO Validations. My responsibilities included:
• Writing and Executing IQ/OQ/PQ Validation Protocols with CMOs.
• Performed Statistical Analysis.
• Wrote Technical Reports.
• Generated NCRs.
• CAPA/SCAR Remediation.

Waltham, MA, US

• I was part of the Quality Assurance Group involved with the management of the Supplier Corrective Action Program. My responsibilities included:
• Supplier Management.
• Supplier Audits of NCR’s, IR’s and DR’s.
• Maintained and Results of Monthly Metrics of Suppliers.
• Performed IQ/OQ/PQ Validations of Raw Materials & Modified Components.
• Qualified Supplier Development of New or Modified Components.

• I was part of the Quality Assurance Group involved with the management of the Supplier Corrective Action Program. My responsibilities included:
• Supplier Management.
• Supplier Audits of NCR’s, IR’s and DR’s.
• Maintained and Results of Monthly Metrics of Suppliers.
• Performed IQ/OQ/PQ Validations of Raw Materials & Modified Components.
• Qualified Supplier Development of New or Modified Components.

Participate in Design Review Phase as part of Risk Management remediation.

Bachelor Of Science Degree, Industrial Engineering

Project Management Certified

Education record