PROFESSIONAL SUMMARY

Strategic quality assurance and operations support management with over 14 years of experience with extensive knowledge of quality policies, driving quality operations verification and validation support (V&V) processes for regulated Aviation, Medical and Consumer manufacturing.

Champion multi-site operations for quality management systems certification and alignment to regulated FDA (QSR) 21 CFR part 820.22 (Quality Audit Management), 820.25 (Personnel/Training) 820.40 (Document Controls) 820.100 (CAPA) for manufacturing of class I, and class II and Class III products, thorough knowledge cGMP’s. QSR’s, ISO for medical products.

Development of Quality Assurance Teams to continuously monitor, evaluate and provide recommendations to executive management team in regards to improving and increasing efficiency of quality management system utilizing ISO 9000:2000, AS9100, FAA, IPC-610 and ISO 13485 concepts. Process oriented, yet flexible, with strong analytical skills and creative problem solving capabilities, demonstrates resourcefulness and versatility in responding to change and shifting priorities including internal and external field service quality programs with understanding and implementation of SOP’s and Audit Plans.

Excellent interpersonal, verbal, and written communication skills with the ability to interface with people at all levels of the organization. Solid ability for independent judgment to troubleshoot issues/concerns, determine and execute next course of action

Thrives on building effective business relationships and strong follow up skills with ability to work in a fast paced environment.

Highly proficient and creative in using MS Outlook, Excel, PowerPoint, Visio, Word. Experience in SPC, Six Sigma, FMEA for cross functional activities to address improvement program such as: cost reduction, Root Cause Analysis, Risk assessment ISO:14971 Utilizing latest methods to identify and eliminate possible failure causes.

ACHIEVEMENTS

LEADERSHIP: Developed & administrated Quality Cost Control programs reaching over 5000 customer’s managers and thousands of employees, continuous improvement, process improvement, logistics, quality assurance, for lean manufacturing systems, with primary objective to develop and enhance existing Business Process Management functions related to FDA (QSR), 21 CFR part 820.50 (Supplier Management Control).

EDUCATOR / MENTOR: Design of training curricula; implementation of training programs; train & mentor junior engineers and managers; provide training in Process Validation (IQ, OQ, PQ), FMEA, SPC, ISO/QS9000, 13485, and DOE. Results are improved product life, reduced variability, warranty savings, rework reduction, scrap reduction, and customer satisfaction resulting in 15% growth in business in one year.

Guided the company’s five European operational divisions to align with FDA regulations and the first time certification to ISO 9001:2000 series (newly adopted system by the SQS “Swiss Quality System Auditors”) for the first time in my company history.

Participated in engineering design team meetings to address and review quality concerns in reference to customer design requirements and provided technical support in order to assure smooth transition of the product requirements from engineering to manufacturing production lines per regulation (21 CFR Part 820.30 “Design Control”).

EXPERIENCE

1/2015-Present

GIL Intl CSVS – Valencia, California - International Management Consulting Firm –Senior Consultant

Oversight of the day-to-day activities related to the quality and safety of client products for compliance with ISO: 14971.

Established and implemented the quality systems to maintain compliance with applicable domestic and international regulatory requirements based on client’s specification.

Ensured non-conformances and CAPAs are implemented as required to maintain suitability of client’s related products.

Administrated quality system audits are planned, performed, and necessary corrective and/or preventive actions are taken in accordance with established customer procedures.

Developed, implemented and verified procedures for the inspection/ verification of client’s products and services.

Oversight and administration the documentation system, change control, and ensured Good Documentation Practices are followed.

Communicated the status of the quality system to client’s management through the use of established metrics and reports.

Overseen recalls and post market surveillance, including customer product complaints.

Collaborated with client’s manufacturing on product and manufacturing changes and ensures verification/validation activities are appropriately executed.

Responsible for customer employee training system and tracking to meet operational, regulatory, and accreditation requirements.

Administrated and directed continuous improvement activities at several clients manufacturing sites.

Assured compliance with the SOP Manual (SOPM) regulatory requirements and has responsibility and authority to approve or reject, as well as discontinue processing and/or release of product when deviations from the SOPM warranted.

Acted as liaison for collaboration with the other internal departments with appropriate local, national and international regulatory authorities, including FDA and other agencies.

Ensured compliance with all applicable federal, state, and local accreditation requirements, company policies and standard operating procedures.

Overseen the review and approval of product and manufacturing quality controls and changes for adherence to quality system requirements.

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EXPERIENCE (CONTINUED)

8/2011 - 11/ 2014

Boston Scientific Neuromodulation –Valencia, California - Implantable Medical Devices

Sr. Sterilization Engineer

Provided technical solutions for Class III, implantable product development to organization and manufacturing to achieve EtO validated sterilization processes and ensured product biocompatibility for new and existing products.

Collaborated with other technical departments for implementation of resolutions to new and existing problems that aid both the product development, process validations and supplier quality management within manufacturing teams.

Independently supported production activities, R&D validations for sterilization and other related regulatory requirements relevant to FDA submissions including supplier overview audit planning and audit management.

Administration and documentation of all related quality and operational programs including supplier quality involving contract sterilization for newly developed, manufactured prototype Class III products.

Reviewed and approved process for developed customer specific sterilization cycle and process parameters to comply with local, state and federal regulatory agencies such as OSHA, FDA, and AAMI.

Provided new product development sterilization / microbiology validation support for compliance to AAMI 11135, ISO 10993-7 and other applicable regulatory requirements.

Performed, coordinated, executed, and summarized all areas of sterilization validation (EtO).

Used well developed knowledge based matrix of product sterilization to assess and supply strategic direction for sterilization.

Worked with other departments to design and validate manufacturing process validations and sterilization cycles for new products..

Provided project management support activities through all stages of manufacturing and sterilization including test design, cycle optimization and certification for utilized chambers. Communicated and reviewed these plans with management or project leaders for submission and approval in PDM.

Worked independently to develop, implement and maintain monthly sterilization processes matrix for both in –house and external subcontracting facilities to assess and evaluate feasibility and operational capabilities within the Microbiology organization.

Reviews products, processes, and material related nonconformance for technical accuracy, completeness, and justifications supporting recommended actions to be taken.

10/2005 - 6/2011

Medtronic Diabetes – Northridge, California - Implantable, External and Disposable Medical Devices

Sterilization Validation Specialist

Provide technical solutions to product development organization and manufacturing to achieve EtO validated sterilization processes and ensure product biocompatibility for new and existing products.

Offered and implemented original solutions to new problems that aid both the product development process and manufacturing. Independently developed approach to solutions; worked effectively as part of a R&D lab team.

Administration and documentation of all related quality and operational programs involving supplier quality management,contract sterilization for newly developed, manufactured medical Class II, Class III products.

Review of the design and approval process for developed customer specific sterilization cycle and process parameters to comply with local, state and federal regulatory agencies such as OSHA, FDA, and AAMI.

Oversight of all quality and manufacturing assurance functions in design and development of disposable manufactured products for application of Class III, Implantable Products by Medtronic Inc.

Provided new product development sterilization / microbiology validation support for compliance to AAMI 11135, ISO 10993-7 and other applicable regulatory requirements.

Performed, coordinated, executed, and summarized all areas of sterilization validation (EtO, radiation, and steam).

Used extensive knowledge of sterilization processes to manage company objectives which included complying with regulatory requirements, meeting schedules, and minimizing costs to produce high-quality products.

Worked independently to design, validate, implement and maintain new sterilization equipment and cycles for production products. Authored IQ/OQ/PQ plans/reports, calibration procedures, assembly procedures and user instructions.

Provided project management through all stages of sterilization including product design review, test design, cycle optimization and certification. Communicated and reviewed these plans with management or project leaders.

11/2004 - 10/2005

PMP Inc. – Carson, California - Class I Medical Devices, Contract Sterilization Facility

Quality Manager

Administration and documentation of all related quality and operational programs involving injection molding products and contract sterilization for newly developed, manufactured medical Class II, Class III products.

Developed and designed Sterilization cycles for Implantable Medical products for Boston Scientific, Advanced Bionics and Medtronic.

Review of the design and approval process for developed customer specific sterilization cycle and process parameters to comply with local, state and federal regulatory agencies such as OSHA, FDA, and AAMI including PCB and other electronic component.

Oversight of all quality and manufacturing assurance functions in design and development of injection molded disposable manufactured products by PMP Inc. (i.e. Petri Dishes, Specimen Containers, Drosophila, 24 Hours Urine containers).

Overseen the performance of specific QA functions, including product release, document control and quality assurance engineering, to assure that products and processes meet company and regulatory requirements/standards.

Responsible for staffing, training and development of subordinates, and the control of financial resources to maintain and improve product quality and systems consistent with department and company operating objectives.

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EXPERIENCE (CONTINUED)

2/2003 - 11/2004

GIL Intl CSVS – Valencia, California - International Management Consulting Firm - Consultant

Responsible for review of current quality management system, to develop, direct, and coordinate the execution of implementation of regulatory strategies mandated by “21CFR Part 820” for the FDA (483) applications involve in PCBA and other electronics.

Supported in planning and facilitation of administrative function assigned to several work streams and supplier quality management involving EtO sterilization process, review and streamlining processes within the manufacturing to comply with regulatory requirements for Welch Allyn Medical Portland Oregon. “Design, Manufacturing and distribution of Medical Monitoring Systems and PCBA verification V&V process”.

Negotiating and communicating effectively both internally and externally with cross-functional supplier’s project teams, management, regulatory agencies (i.e. FDA, TUV) and business partners to ensure objectives of programs are met on time for harmonization of division policies with Welch Allyn Corporate policies (Internal Audits, CAPA, Design requirements “Gate System Protocol”).

Reporting to the president of the organization, responsible for review and upgrade of existing quality management system in reference to ISO 9000:2000 and FDA (QSR) 21 CFR part 820 regulations for supplier ACCURATE ELECTRONICS Chatsworth California.

Oversight of development for documentation, and training assignment for the newly revised quality assurance department.

System and application development for in process and pre-production quality functions in respect to supplier JIT & CRM capacities.

Administration functions in the development and issuance of written procedures, Bills of Materials and product drawings, ensuring that the company complied with the requirements of its cGMP’s and those of the regulatory agencies.

Ensured that Quality Assurance department policies and procedures are maintained and department personnel are operating in accordance with established procedures.

10/2001 - 2/2003

LEMO USA - Rohnert Park, California - Manufacturer, Distributor of Electronic & fiber Optics Class I products for Medical, Industrial & Military applications

Quality Manager

Administrated, directed organization’s quality system development, documentation & implementation for ISO 9001:2000 & FDA 21 CFR Part 820 (Quality System Regulations), ISO 13485 compliance. Defined process requirements and validations for all Business functional activities, documented improvement concepts to enhance customer and supplier quality management support functions.

Over sight of quality functions for transition of several newly designed injection molding disposable medical Class I product lines into manufacturing. Directed review and approval process Design Review & Validation, and Verification for customer related issues including monitoring & measuring the CAPA process, MRB activities for Components used in Class II Medical products.

Development of department strategic planning using Hoshin Planning system. Directing activities around the cost of quality program. Internal Audit programs reviews for division in USA & other international subsidiaries including global quality and regulatory requirements for medical device manufacturers, including: CMDR. Coordinated with vendors/suppliers to determine product specifications, regulated by agencies such as: FDA, OSHA in reference to final product release for organizations such as:

(ALCON Surgical, Biosense Webster, Stryker, Cardima Welch Allyn Monitoring System, ArthroCare & Medtronic).

8/1991 – 8/2001

ACB Kuwait - San Diego, California -(Turnkey, Consignment) of Commercial Industrial Products

Quality Manager

Reporting to the Division President was responsible to oversee and directed the manufacturing and quality teams across several sites as the Product Support Manager for KARCHER (AMERICAN KLEANER), (Had cross-site management responsibility (USA, Europe & Africa’s), manufacturing commercial and military mobile kitchens for battle ready applications, and commercial pressure washers currently offered at Costco.

Responsible for resource allocation, including budget and personnel. Overseen the hiring and maintenance of a highly trained staff.

Reporting to site General Manager administrated Quality Assurance disciplines as site QA Manager for IBA (Contract Sterilization Facility) processing manufactured and packaged medical products for Industrial Sterilization processing Plants utilizing ETO as primary substance for companies: Allegiance, Tyco Medical. Cardinal health and many others.

Under general direction/supervision, assisted in the development, documentation & implementation of quality standards in reference to manufacturing & environmental packaging including (sheet-metal) fabrication & other components used in Philips class II Medical products. (DMR, DHR).

Created, implemented activities for support of quality in manufacturing areas for systems that are related to inspection and validation of protocols for Dental X-Ray systems developed and manufactured by Philips North America. Ensured conformance, to in-house specifications, Current Good Manufacturing Practices (CGMP)/QSR (21 CFR part 820.90).

Reporting to the Manager of Quality Assurance for TA MFG (Esterline), was responsible for quality activities as Quality Assurance Engineer for development and manufacturing of commercial and military Clamps, Line Blocks, and Specially Molded Elastomers.

Reporting to the Manager of manufacturing for KAVLICO, was responsible for all automation production activities as Manufacturing Engineer for development and manufacturing of fluid detective sensors for oil pressure and break fluids for automobiles: VOLVO, BMW, FORD, GM product lines responsible for manufacturing design and development of LVDT devices for commercial and military aviation applications.

Reporting to the Manager of manufacturing for SDI, was responsible for all automation production activities as Manufacturing Engineer for development and manufacturing of pyrotechnics & explosive ordnance used in commercial air bags and military applications.

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1/1990 - 10/1991

HR. TEXTRON – Valencia, California - Manufacturer of Commercial and Military hydraulic flight controls

Mfg. Engineer HR Division.

Provided Technical support to program management groups for on-time delivery of hydraulic flight controls on assigned programs such as: Air Force 1, 747-400, C-17, AH 64, FA-18, Bell 212, 214 & NASA’s Shuttle Program.

Executed manufacturing objectives for the development, environmental packaging of manufactured, or returned products for overhaul & recertification for flight worthiness.

Provided 24/7 live technical support to internal & external customers for evaluation and diagnostic issues and repairs, including customer interface to resolve the contractual issues in reference to product development, manufacturing installation and operational capabilities. Conferred with planning and design staff concerning product design and tooling to ensure efficient production process control and proper manufacturing and material availability to complete projects.

8/1985 - 11/1989

SIERRACIN TRANSFLEX – BELL, California - Design, manufacturer of specialty electronic Flex circuit boards Medical Class II Devices

Mfg. Engineer

Negotiated feasibility with engineering design groups for development, manufacturing of electronic devices such as flexible printed circuit boards for commercial / industrial automotive, Medical class II applications.

Supported manufacturing personnel, staff during new product introduction, design for manufacturability programs and improvement functions. Designed and develop processes and tooling to manufacture products to customer specifications. Interfaced with customers to determine customer specifications

Developed, analyzed to improve Bills-Of-Materials, manufacturing planning and work instructions.

EDUCATION

Bachelor Degree in Mechanical Engineering Technology A&M University Normal Alabama

May 1985

Certificate of training in Advance Supervisory & Management Sponsored by H.R. Textron

August 1990

Certificate of training in Failure Mode & Effect Analysis Sponsored by Kavlico Corporation

July 1998

Certificate of training in ISO 9000 Series Internal Auditing by Alliance International

June 1999

Certificate of training in Lean manufacturing Sponsored by ISOMAX of California

August 1999

Certificate of training in Six Sigma Champion Black Belt Sponsored by ISOMAX Of California

July 2000

Certificate of training in Quality Management System Lead Auditor ISO 9000:2000 with emphasis on Medical Devices (ISO 13485:1996) Excell Inc.

November 2001

Certificate of training in ISO 9000:2000 Series Development & documentation Excell Inc.

November 2001

Certificate of training in Industrial Sterilization of Medical Devices

March 2005

Certificate of training in Lean Business Practices Sponsored by Boston Scientific

February 2012

Certificate of Operations Management BAYT Expert Rating

May 2016

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