Sr. Supplier Quality Engineer partnering and collaborating with suppliers for NPI and sustaining products for Class I, II and III medical devices. Working with suppliers to complete PPAP process, SPPC for changes in the approved processes, SCAR, NCR, CAPAs, audits and trend overall performances. Performing the required functions utilizing the following software applications, SAP, Documentum, Work Front, Agile, Teams, Adobe Pro, Power BI, SharePoint, Microsoft office suite and Dashboard.

Provided time line and monitoring tools to manage the scope and execution of the EU MDR compliance activities. Providing updates and identifying critical path activity to ensure timely execution of the required task to meet the required submission scheduled timeline. Ensure management was fully informed of the progress and projected plan to meet the timeline in the most economical and efficient manner. Provided support to multiple clients from 2021 to present like Zimmer, Paragon, G&H Orthodontics, Viant Medical, DJO Medical, etc..

REMS auditor to the pharmacies dispensing to male and female patients. Scheduling and coordinating audits to be performed remotely. Risk Evaluation and Mitigation Strategies (REMS), A required risk management plan that uses risk minimization strategies beyond professional labeling to ensure that the benefits of the drug outweigh the risks. Must meet requirements of 21 CFR 208: MG can be required if FDA determines one or more:– Patient labeling could help prevent serious adverse events– The product has serious risks that could affect patient’s decision to use or continue to use – Patient adherence to directions is crucial to product effectiveness.Received training to Ambrisentan REMS Certified Outpatient Pharmacy Training version 6.

Perform validation activity for remediation and in support of the EU MDR compliance strategy per G&H Wire Company, Inc. Master Validation Plan (MVP) which is a retrospective strategy to bring into compliance the equipment, processes and test methods utilized in the facility. The validation plan identifies the legacy processes performed at G&H Orthodontics, provides criteria for assessing whether these processes need to be validated and establishes a program for executing subsequent planned validations. The completed assessments serve as the Master Validation Report. The Report was released and revised as assessments are completed.

Remediation of process deviations to ensure compliance to the product specification and efficacy of the product design intentions.

Performed an onsite audit of the facility and systems controlling the manufacturing environment in preparation to the Pre Approval Inspection by the regulatory agency.

In support of the national response to the Covid -19 outbreak within the continental United States of America.Retired after 37 yrs of service as a combat engineer for 12 yrs and air defense for 25 yrs on January 31, 2021

Plant undergoing EU MDR compliance upgrade. As a member of project team and under the Paragon organizational structure in cooperation of Sales, Procurement and Regulatory, my duties would include proper guidance and support to transmit the associated documentation for OEM and Contract Manufactured Products and processes from one facility to another through interstate transfer in support of the customers goals to be compliant to the new EU MDR regulation. This would mean planning with the customers to ensure proper documentation was identified and accurate prior to sending to the sites. Liaison between the customer to adjust for Variants documentation and the Brexit regulatory change from the UK to the NL.

Perform auditor responsibilities to ensure the activity performed supports the remediation plan and product safety to the customer/end user. Review IC procedure as it compares to the revised SOP to incorporate the Interim Control (IC) procedure requirements going forward. Verify the effectiveness of the training of personnel and their utilization of the procedures.

Assigned to resolve and track NCR's initially and work with manufacturing to improve the quality of the process in order to reduce NCR's and repeated occurrences. Provided a significant reduction in open NCR's, Prepared IP Sheets and Ballooned DWG's in support of NPI and the associated ECO's. Provided technical support for process improvement in the management and execution of the NCR program and related CAPA's along with SCAR recommendations in support of Supplier Quality functions.

Preparation and executions of the HHE process for Knees, transitioned into NPI for Persona revision knee development. Performing review and approval of Special Work (SW) Router Request, FCA/FCP, Design review, Print Review, Define and establish Inspection Methodology and selection of gaging device.

Plant consolidation project for lean manufacturing.As a member of project FOOT PRINT team and under the Tecomet organization of Sales and Procurement, my duties would include proper guidance and support to transfer the products and processes from one facility to another through interstate transfer. This would mean planning with the customers to ensure proper bank build was established from the sending site so that there was no gap in the product chain during the transfer and validation within the receiving site. The qualification of the facility, utilities, equipment and processes that were to be used for the manufacturing of Class I, II & III medical devices must be established prior to submission of First Articles to the customers. This activity included the planning and execution of decommissioning equipment and processes for relocation to include resolution and closure to CAPA issues identified during the process. Provided leadership and guidance in the development of TMV process, Commissioning, Validation and MVP document.

Validation activity for the CIP/SIP system for project 5099 to include the execution of DQ, IQ, OQ and PQ protocols.Develop form based protocols to execute for biological production systems to include Ultra Filtration Skids, CIP Skids, Tank modifications, Agitator placements, WFI distribution piping systems. Executions include review and approval of ETOP and FAT punch list closures, system walk-downs using P&ID drawings and Ladder Logic Diagrams for panel emplacements to control the systems.. Write summary and final reports for protocol closure Provide peer review for associates validations activity and report writing for the completed protocol

Develop and execute protocols for the facility HVAC systems, High Purity Water Systems, BMS software system and BAS software systems. Provide peer review for associates validations activity and report writing for the completed protocols.

Sr. Quality Engineer in charge of TMV and PV activities per approved Master Plan design to remediate quality issues outlined by the regulatory agency, FDA. The effort includes but not limited to Variable and Attribute test methods, Process Validation for facility, utlities, equipment and processes for all products manufactured at this facility.

As a member of the quality team for Trauma, my duties would include remediation activities for Process Validation (IC-9) within packaging and labeling, Remediation of NCR’s that were long overdue for corrective action, establishing product specific packaging requirements and remediation of the Design History Files (DHF) for the Class II & III product lines, implants and instruments. Utilized Zimpack to identify the packaging setup sheets with instructions for use (IFU) and the labeling requirements for the product use, identification, storage and handling. Interfaced with the suppliers to identify resolutions for the NCR’s related to their products and use of material by Zimmer.

Providing a resource plan to support the operational and project goals. coordinate the staffing and placement of resources to support specific tasks assigned to achieve the business goals and intent. Schedule and plan the delivery and set up for the project needs in order to deliver the expected results on time and within the scope of the budget. Coordinate with customer SME to facilitate the execution of the project plan. Provide a summary of progress and status of the project milestones to indicate to management the confidence for an on time delivery of the project goals.

As a member of the GxP Systems team and under the Invacare organization of Process Engineering, my duties would include proper guidance and support to commission and validate the facility, utilities, equipment and processes that will be used the manufacturing of Class I & II medical devices. Instrumental in developing a validation system within quality to ensure adequate testing for reliability and reproducibility of the manufactured parts and assemblies. Provided leadership and guidance in the development of TMV process, Commissioning, Validation and MVP document.

As a member of the product development team and the organization of quality, my duties would include proper guidance and support to verify and validate the equipment and process that will be used to produce the new product design. Prepare appropriate measurement techniques and methods that would provide an accurate representation of the product specifications to the design drawing. Prepare documentation and validation for product transfer for domestic and international involvement.

Perform gap analysis of the quality system. Develop Master Validation Plan and revise procedures to remediate the observations noted in preparation for revalidation activity that would close the gaps and increase the confidence level going forward.

Define, document and implement validation master plans for remediation activity associated with EP Catheters. Safire BLU, Safire TX, Cool Path Contact, Uni-directional and Bi-Directional catheters. Developed and executed attribute and variable Test Method Validation protocols and reports for the inspection processes. Developed and executed Process Performance Qualification protocol and reports for EP Catheters. Safire BLU, Safire TX, Cool Path and Bi-Directional Cool Path catheters..

Performed quality assessment, gap analysis of the production processes utilized in production of diabetes strips at the Whitney, Oxfordshire facility. Reviewed the findings with the management team for Abbott and to discuss remediation activities necessary to remedy the gaps that would restore the confidence in the product produced in the manufacturing.

Submitted pre-audit surveys to suppliers providing services to Gyrus, Olympus. Prepared audit schedule for suppliers needing to be audited by classification. Prepare audit agenda for full quality audits to ISO 13485 or specific audit to ISO 17025. Led audits per established agendas. Submitted closing oral and written reports at the end of the audit to Gyrus for their review and continued evaluation..

Remediated 483 Observations identified in a 2009 audit. Prepared and presented responses to the regulatory agency as to the plan progress and performance of the remediation activity, and provided technical support to quality and regulatory personnel that achieved a higher level of regulatory compliance. Prepared and implemented a QSIP program to improve product quality and compliance with regulations. Led critical CAPA projects associated with field product failures, including root cause analysis and implementation of corrective actions.Additionally, developed SOP’s and Work Instructions, Training Curriculum, Validation and CAPA Project Plans,, Requirement Specifications, Traceability Matrix, IQ/OQ/PQ or CQ protocols with associated Test Cases and Final Reports. Also, audited training programs and provided training to the trainers.

Responsibilities as the Sr. Quality Engineer included development and execution of a shelf life process that would comply with domestic and international regulations. Started at the Minneapolis facility and transferred to a facility in Warsaw, IN for Global Quality Improvements. Owned multiple CAPA’s related to shelf life, contract manufacturing and product functionality, and drove these CAPA’s to closure.The products that are revalidated will in many cases extend the expiry date from a 3 year shelf life to 5 or even 10 years. This effort will reinforce the present claims as well as extended the storage life of the product for longer periods of time. The procedure, protocol template and report template was developed in this process to expedite the use and training of this procedure. Training was performed for manufacturing engineering, product development and marketing.Performed risk analyses on existing products by define the process flow and determining through fault tree analysis what potential failures could occur. The potential failures were examined for redesign, control measures or training. GAP analysis was performed for the Design FMEA for the product and for the Process FMEA for the manufacturing process to ensure compliance to the end user’s specifications as related to the relocation of a manufacturing venue. Led a cross-functional team through the development of the project plan for validation, risk assessment, and developed a PFMEA to ensure that the product was maintained in a validated state at the completion of the project. The facilities, utilities, equipment were examined closely to ensure proper operation and maintenance reliability. Protocols for Cleaning Processes, Gamma Sterilization and Packaging Processes were developed and executed. Additionally, statistical analyses of process capabilities were performed, and the reliability of calibration and maintenance systems was determined.

Work on a project directed by RCA to qualify the facility, utilities, equipment and processes for the commercial medical device products. Establish a Master Validation Plan, Policies and procedures for validation activities, develop qualification protocols for the intent of validating the facility, utilities, equipment and processes.

GYRUS ACMI, Bartlett, TNSr. Quality EngineerQuality System Technologies of Anderson, Inc. (QST), Belton, SCDirector of OperationsDeveloped and executed protocols for software validation Gage Insite Calibration Program located in Memphis, TN. Provided validation training and quality support of the calibration program at the Memphis facility. Developed and executed validation documentation for the Class 8 (100,000) Clean Room in Saltillo, MX. Audited legacy validation data and facility SOP’s per 21CFR-820 and ISO 13485 requirements, then opened and initiated several CAPA’s to address system deficiencies that caused the observed gaps, and wrote improved procedures and trained employees.

Performed a gap analysis against 21CFR-820 and ISO-13485 requirements for qualification of attribute and variable test methods, and then conducted remediation activities to close the gaps through revalidation and other corrective actions. Statistical analyses were performed to determine repeatability and reproducibility of test methods, as well as the process capability to detect defective product from acceptable product during Project Horizon

Mobilized for active duty in support of Homeland security

Organization developed to provide sound quality and regulatory support to industries regulated by the FDA with an emphasis for Pharmaceutical, Biotechnology and Medical Device manufacturers. Committed to providing the support new product development, pre-approval inspection for new or relocated manufacturing sites domestically or internationally. Offering guidance and support to define gaps in compliance, mitigate and remediate the observations to satisfy regulatory agencies and the manufacturers needs for intended use.Director for over 30 personnel in 7 geographical locations that I have managed from California to the east coast and from Delaware to Florida at facilities such as Playtex Products, Tyco Kendall, Bausch & Lomb, Abbott Labs, Oread, Welch Allyn from Jan 2000 to Jan 2012. The personnel I selected, staffed and supported were utilized for new product development, 483 remediation’s, calibrations, process validation and training. Responsibilities included the execution of Validation Protocols (IQ, OQ, PQ, PV, DV, and SW), training client personnel in the current regulations and industry standards in the development of quality documentation to support manufacturing environments such as; Bulk Chemical Pharmaceutical products, Medical Devices, Finished Pharmaceuticals for prescription and over the counter (OTC), Biotechnology services and automated equipment/process systems. Validation protocols were developed and executed for several automated manufacturing processes. The scope of the validation process included the development of Standard Operating Procedures (SOP) for the operation, maintenance, calibration, and cleaning processes and Calibration System, Document Control Procedures and Validation Documentation. Quality documents included but were not limited to Master Plans, Protocols (IQ, OQ, PQ, PV, DV, and SW) and production records.

Director for a team of 10 personnel in multiple location where the personnel were utilized to perform software validation, process validation, audits, CAPA plans and remediation activity to prevent a consent decree from being issued by the FDA. The personnel were working in Glendale, CA; Thousand Oaks, CA, Duarte, CA, LA, CA; Lessines, Belgium; and Austria.Developed Validation Master Plans and Validation Protocols (IQ, OQ, PQ, PV, DV and SW) supporting Manufacturing at a Biotechnology Division of Baxter Healthcare. Additionally, set up a CAPA program. This included initiation, planning, assignment of CAPA Owners and program oversight for multiple CAPA’s needed to resolve Quality System and Manufacturing Nonconformities that had been identified through internal audits.

Lead the Validation Team through PAI for the new facilities of Covance and Human Genome Sciences.Responsibilities include developing and executing for the performance & process validation. The process validation consisted of review and approval of the Engineering Installation Manuals produced by Fluor Daniel personnel as substitution for the Installation Qualification (IQ), the development and execution of the Operational Qualification (OQ) and development and execution of the Performance Qualification (PQ) protocols for the facility, utilities, equipment, processes and automated/software systems. This contract manufacturing facility is uniquely designed to be totally controlled through automated/software services such as; Building Maintenance Systems (BMS), Manufacturing Environment Systems (MES), and Distributive Control System (DCS). These systems monitor and control all of the manufacturing functions for this facility. As the Sr. Validation Specialist the additional responsibilities for protocol reviewer for these systems were performed to ensure that the validation effort put forth was satisfactory.

Developed Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for a new Biogen Facility (biotech), located in the Research Triangle Park. The protocols developed were for the facility, utilities, equipment and processes. Was instrumental in clarifying several GMP issues that were in question as they attempted to answer the needs of the protocols. Performed training operations to assist fellow colleagues in the cGMP requirements. Training included the proper procedure in developing and executing validation protocols.

Responsibilities included the development process for quality documentation in support of the manufacturing environments such as; Bulk Chemical Pharmaceutical products, Medical Devices, Finished Pharmaceuticals for prescription and over the counter (OTC), Biotechnology services and automated equipment/process systems. Prepare Validation Master Plans and Protocols (IQ, OQ, PQ), Standard Operating Procedures, and production records. Validation protocols were developed and executed for systems like the Software for Delta T Illusions Casting Machine, Software and equipment validation for the Auto Inspection System (12), the Print Tint Machine (4), and Optoform 50 Lathe Machines (12), Lyophilizer, Desiccators, Sterilizers-AMSCO/Fedegari/Getinge, Laboratory Analytical Equipment and several manufacturing processes

Project Manager and Facility Engineer responsible for continuous improvements, relocation of prduction process through interstate transfer. Design and automation of utilities, equipment and processes throughout the manaufacturing of pharmaceutical products for prescription and OTC drugs.