Robert Theo Charles

*** ********* **. ****

Montgomery, TX 77356

Home Phone: 936-***-****

ad12el@r.postjobfree.com

Cell Phone: 936-***-****

SUMMARY

Self-motivated quality and regulatory management and engineering professional with extensive experience in the medical device and consumer products industries. Working experience with ISO-9000, ISO-13485, ISO-14971, 21 CFR Part 820 - Quality System Regulations, AIMD, MDD, MDR, Canadian Medical Device Regulation and related standards. Hands on experience in quality engineering. Proficient at writing quality system procedures, process control and inspection/test documents. Proven hands-on experience with CAPA, Management Review, Process Control, Process Validation, Internal Audit, Risk Analysis. Supplier Quality, Training and Design Assurance support. Experienced in risk analysis and non-conformance investigation and dispositioning. I have proven abilities in planning and implementing change and motivating cross-departmental teams. I have well-developed communications and problem-solving skills. Thrives in a fast-paced challenging environment.

PROFESSIONAL EXPERIENCE

InGeneron, Inc. 2/2022- 8/2023

Director of Quality - Houston, TX

Responsible for assessing the current Quality Management System and implementing changes to assure compliance with FDA Part 820 Quality System Regulation, ISO-13485 and ISO-14971.

Identify and establish a Cloud Based PLM (Product Lifecycle Management and QMS (Quality Management System) and EU MDR (Medical Device Regulations).

Establish and manage an Internal Auditing program using existing company human resources.

Develop a company training program to education the staff and employees on the requirement of a Quality Management System in the Medical device industry.

Millar, Inc 3/2021-2/2022

Sr. Quality Engineer - Houston, TX

Provide Quality Engineering support for manufacturing and development projects for a pressure catheter development and manufacturing company.

Provide manage the review and dispositioning of non-conformances.

Provide support for the internal, customer and supplier audits.

Perform other support functions as assigned by the Quality Engineering manager.

InCube Labs, Inc. 12/2016-3/2021

Quality Manager/ Sr. Quality Engineer - San Antonio, TX

Implement the InCube Labs corporate Quality System at the San Antonio facility and represent Quality Management on all activities at the San Antonio facility.

Establish the Design Control process for new product development.

Lead the development and implementation of Risk Management.

Perform and/or support Receiving, Receiving Inspection, Risk Control and Management, Non-Conformance Management and disposition, CAPA, Calibration, In-process and Final Inspections and Internal Audit.

Develop training protocols for site personal.

Trained and managed Quality Engineer.

Contract Sr. Quality Engineer 06/2016-10/2016

NxStage Medical, Lawrence, MA

Providing Design Assurance support for medical device disposable products line.

Contract Quality Systems Consulting/ Lab Support Corp. 11/2015-4/2016

VGXI Inc., The Woodlands, TX

VGXI is a Contract Manufacturing Operation (CMO) engaged in the phase 1 and phase 2 manufacturing of DNA plasmids. Responsibilities included providing leadership to the Quality Assurance, Quality Control, Validation and Calibration functions.

Completed an assessment of the Drug Regulatory requirements across various countries and their impact to the company’s phase 1 and 2 clinical GMP requirements.

Quality Systems Consulting 4/2015-11/2015

Validation Engineer - Phillips-Medisize in Hudson, Wisconsin

Responsible for writing Validation Plans for manufacturing equipment with embedded software, performing Computer Software Risk Analysis, writing Test Cases, writing IQ/OQ and PQ protocols and Summary Reports.

Quality Systems Consulting

Quality Engineer - Phillips Medisize in Menomonie, Wisconsin

Responsible of operations support for medical device verification and validation product builds. In this capacity I wrote ECO’s and Deviations, perform Risk Assessments, documented and reviewed for non-conformances and process events. Initiated and disposition non-conformance reports, wrote investigation plans, identified root causes and CAPA plans for production issues.

1/2015-3/2015

Quality Systems Consulting/ QUAL COMP CONSULTING

Quality Systems Engineer at Maquet Medical in Wayne, NJ. Responsible for developing and implementing Quality System policies, standard operating procedures and work instructions in accordance with GMP and ISO regulations. Performed gap analysis on existing procedures, proposed modifications for clarity and compliance, initialed the required documents and processed through approval and training.

VALIDANT CONSULTING 7/2014- 10/2014

Quality Assurance Engineering Professional

Subject Matter Expert for Materials Control Work Stream at Fresenius Medical Care. Assessed policies and SOPs compliance with cGMP, ISO, Mexican and Canadian regulations. Evaluated regulatory agency observations against the as-is state. Conduct gap analysis of as-is processes, identified the root causes and developed and implemented corrective action plans.

RCM Technologies 5/2014 – 7/2014

Quality Assurance Consultant

Assigned to Atrium Medical in Hudson, NH for Quality Engineering support of MRB. Worked with process owners to document the non-conformances, containments, risk analyses, investigations and corrective action requirements and results of the effectiveness checks.

OXFORD GLOBAL RESOURCES 12/2013- 3/2014

Independent Quality Assurance Consultant

Assigned to Greatbatch Medical in Fort Wayne, IN for remediation of CAPA files. The project involved the development of a remediation plan, assessing the regulatory risk associated with each CAPA file and executing the plan for addressing deficiencies. Remediation activities included External and Internal Auditing, Complaints and Internal Processes.

9/2013- 10/2013

Quality Assurance Management Professional/ BLACK DIAMOND GLOBAL RESOURCES/PAREXEL CONSULTING

Assigned to Zimmer Corp. Warsaw, IN Corporate Quality and Regulatory for remediation assignment of CAPA and Quality System issues.

oConducted audit of active CAPA files

oWrote remediation protocol.

oProtocol written and approved however the project was cancelled.

Validant Consulting 7/2011 – 5/2013

Quality Assurance Management Professional

Assigned to Terumo Cardiovascular Systems to assure that quality system issues identified by FDA, third party auditors and internal auditors were effectively migrated. This assignment included providing quality systems support to operations, materials management and production. I was responsibility for management of the CAPA remediation projects, implementation of a revised management review process and automation of the Incoming Inspection process. Support was provided for validations, product and process development, manufacturing process control, complaints/recalls, internal audit and quality control improvements.

Functioned as the Quality Engineering Manager and Quality System consultant.

Interfaced with Operations, Engineer and Quality to assure that all process non-conformities were properly documented, tracked and corrective action implemented.

Responsible for project management of remediation effort for issues identified through NCR or CAPA investigations.

Trained the new Quality Manager and Quality Engineering staff.

Nanomedical Systems, Inc., Austin, TX 3/2008 – 7/2011

Director of Quality/ Regulatory

Tasked with developing and establishing the Quality Management System for a startup Drug Delivery medical device company.

Established the Design Control, Materials Management and Supplier Control, Production Process Control, Quality Management, Environmental Control and Complaint and Post Market Surveillance systems.

Perform duties as a member of a nine-person start-up staff with responsibility for developing and documenting the quality system, supplier qualification, training team members, and supporting design and process development through initiating design risk analysis (DFM.

Micromed Cardiovascular, Inc., Houston, TX 6/2006 – 3/2008

Director of Quality Systems

Established risk management program in compliance with ISO 14971. Re-initiated quarterly quality management reviews and successfully completed FDA, ISO and internal regulatory compliance audits.

Restructured the clinical complaint, post market surveillance and adverse event processes to provide clear process for managing clinical and commercial released product corrective action processes. Provided link to the Risk Management and CAPA processes to manage corrective action.

Updated the in process inspection processes to improve resource utilization, reduce backlog, address process non conformances and yield issues, and improve cycle time.

Initiated review and update of supplier quality assessment process and define/clarify part, material, component acceptance criteria and improve design definition.

Assumed responsibility of Project Manager to assure delivery of engineering projects per established timelines.

Cyberonics Inc., Houston, TX 3/2001 – 3/2006

Director of Quality Assurance and Quality Control

The defined objective of this role was to address complaint, CAPA, quality systems, design control and operations compliance issues which were documented in FDA warning letters. The objective was further defined as assuring that compliance issues did not prevent approval on future PMA applications.

Established and maintained the Quality Systems in compliance with FDA, ISO regulations, and applicable industry and international standards.

Implemented and maintained a comprehensive quality system and represented company during FDA and ISO audits. Interfaced with FDA and ISO representatives as necessary to address compliance observations. Managed the Internal Audit program.

Implemented comprehensive Risk Management System to meet requirements of ISO 14971.

Assured quality of software product, tests, and quality system software in accordance with 21 CFR part 11 and industry standards and regulations through software validation.

Designed and constructed an Environmental Test Facility for component and assembly qualification and life testing. Perform Failure Analysis on manufacturing and field returned product.

Managed Material Review Board, Corrective and Preventative Action Systems, and Risk Management database resulting in a reduction of scrap and rework by greater than 50%.

Developed and organized program management team consisting of process owners from manufacturing, quality, engineering, materials, and clinical to prioritize resources and manage cross function projects.

Worked with the clinical and post market surveillance teams to implement corrective actions to product compliance.

Developed and conducted new employee training and maintained training records.

Managed production inspection function. Established plans for reduction of visual inspection and implementing In-Process Audit concept.

Telxon Corporation, The Woodlands, TX 6/2000 – 3/2001

Vice President of Quality and Reliability Engineering

Accountable for establishing pro-active Quality Assurance, Product Test, and Reliability Engineering programs. Worked with Purchasing Management to established Supply Chain Management process.

Assured primary responsibility for Post Market Surveillance. Developed a Quality Assurance and Customer Satisfaction Strategy to improve the customer satisfaction, quality performance of products and services by correcting product performance issues and providing rapid customer feedback.

Implemented quality improvements that reduced warranty and non-conformance costs, assure compliance with regulatory standards, and reduced overall quality costs.

Realigned Quality Assurance System and addressed system deficiencies to assure compliance with ISO regulations/guidelines.

Established a corporate closed loop corrective and preventative action process with an escalation provision to advise executive management of high profile issues.

Organized and executed a complete re-writing of the Quality manual and operating procedures to reflect pro-active quality controls and initiatives.

St. Jude Medical, Cardiac Rhythm, Scottsdale, AZ/Sylmar, CA 1/1993 – 6/2000

Director of Quality Assurance

Managed the Supplier Quality, Quality Assurance and Quality Control functions in the Sylmar, CA facility.

Designed and implemented Quality System for start-up Micro Electronics Hybrid Manufacturing facility in Scottsdale, AZ resulting in no observations during ISO compliance audit. Managed internal and supplier auditing programs.

Implemented Supplier Certification program resulted in 97% acceptance rate at receiving inspection and above $300K annual savings.

Managed the CAPA process and actively participated in investigation and corrective action oversight.

Implemented inspection process improvements, statistical process control, and teamwork strategies that resulted in reduction of 40% in non-direct labor budget without change in product quality.

Abbott Laboratories, Irving, TX 1983 – 1993

Site Quality Systems Manager/ Manager of Clinical Chemistry Quality Assurance

Managed Quality Assurance and Quality Control activities for Printed Circuit Board manufacturing, Clinical Chemistry and Microbiology.

Developed and implemented centralized quality/manufacturing strategy for Dallas Operation.

Developed, implemented and managed Failure Analysis and CAPA processes to support development, production, customer and engineering improvements.

Intermedics, Inc., Freeport, TX 1978 – 1983

Senior Quality Assurance Engineer/ Quality Assurance Manager

Performed quality engineering responsibilities which included change review/approval, material discrepancy review, investigation, and dispositioning, and corrective action investigation and tracking in support of pacemaker and accessory production.

Established supplier quality procedures and conduct supplier quality assessments.

Promoted to Quality Manager with responsibility for developing the quality system for the pacemaker accessory production, neurological stimulation production, printed circuit board production facilities.

Xerox Corporation, Webster, NY 1973 – 1978

Sr. Supplier Quality Engineer

Trained and developed as a Supplier Quality Engineering with responsibility for performing supplier quality system assessments, source inspections/verifications, and corrective action investigation/ follow-up.

Completed a two (2) year assignment of management development through Xerox's RAPID (Rotational Assignments Providing Individual Development) Program. Assignments included Purchasing, Production Control, Advanced Product Engineering, and Corporate Management.

Martin Marietta, Orlando, FL 1972 – 1973

Quality Engineer

Entry level Quality Engineer with responsibility for writing quality plans and supporting product manufacturing and inspection operations.

EDUCATION

Bachelor of Science in Electrical Engineering

Prairie View A&M University

CERTIFICATIONS

BSI Management Systems Auditing: Certification Date 1/16/2019

BSI ISO 13485: 2016 Internal Auditor (TPECS): Issues Date: 1/16/2019

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