Benjamin Ghanoongooi's Email Addresses & Phone Numbers

📖 Summary

Senior Sterilization Engineer @ Boston Scientific • 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 and manufacturing teams. • Independently supported production activities, R&D validations for sterilization and other related regulatory requirements relevant to FDA submissions. • Administration and documentation of all related quality and operational programs 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 sterilization cycles for new products.. • Provided project management support activities through all stages of 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.• Reviews products, processes, and material related nonconformance for technical accuracy, completeness, and justifications supporting recommended actions to be taken. From August 2011 to November 2014 (3 years 4 months) Valencia CaliforniaSenior Sterilization Validation Specialist @ Medtronic • 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 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 well developed knowledge of product sterilization to assess and supply strategic direction for sterilization. Assessment was made with knowledge of product requirements, corporate objectives, regulatory requirements, scheduled, cost objectives and personnel quality.•Design and validated sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support. •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. From October 2005 to June 2011 (5 years 9 months) Quality Manager @ PMP Inc Design, Manufacturing of Class I medical products, Contract Sterilization Facility; Administration and documentation of all related quality and operational programs involving 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 by PMP Inc. Developed supplier control, Inspection and reliability processes to comply with Federal regulations such as: FDA (QSR), 21 CFR part 820 quality requirements.Formulated and maintained quality assurance objectives and coordinated objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs. Planed, promoted, and coordinated training activities related to product quality and reliability for ISO 13485. Directed Investigations and oversight of customer complaints regarding quality (21 CFR Part 820.198: Complaint management files).Reviewed of Quality Assurance, manufacturing documents to ensure completeness and accuracy. Ensured final products have been inspected in accordance to specifications & regulations (DHR) 21 CFR part 820.120 (Labeling) From November 2004 to October 2005 (1 year) Principal @ GIL Intl CSvs Inc • 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.• Support in planning and facilitation of administrative function assigned to several work streams 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 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 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. From March 2003 to October 2004 (1 year 8 months) Quality Assurance Manager @ LEMO SA • 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 for all Business functional activities, documented improvement concepts to enhance customer support functions.• Over sight of quality functions for transition of several newly designed 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). From October 2001 to February 2003 (1 year 5 months) Quality Manager @ ACB Kuwait • Reporting to the president was responsible to oversee and direct the quality teams across several sites. (Had cross-site management responsibility (USA, Europe & Africa’s clients QA teams). • Responsible for resource allocation, including budget and personnel. Overseen the hiring and maintenance of a highly trained staff. • Administration of Quality Assurance disciplines for development & environmental packaging of Electronic components used in Class II medical devices, and Industrial Sterilization processing Plants utilizing ETO as primary substance for companies such as IBA, Allegiance , Tyco Medical. Cardinal health• 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). From August 1991 to September 2001 (10 years 2 months) kuwait Middle EastManufacturing Engineer @ HR TEXTRON • Provided Technical support to program management groups for on-time delivery of hydraulic flight controls on assigned programs such as: 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 technical support to internal & external customers for evaluation and diagnostic repairs,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. From January 1990 to December 1991 (2 years) Prog. Engineer @ SIERRACIN TRANSFLEX BELL California • 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-Material (BOMs) manufacturing planning and work instructions. • Applied set up and run times to production processes. Provided job estimates for customer request-for-quotes (RFQ). Analyzed and plan work force utilization, work flow for maximum efficiency. From January 1990 to October 1991 (1 year 10 months) Quality Assurance Manager @ Crystal Mark, Inc. Managing all audits by customers and regulatory agencies including but not limited to FAA & FAA Repair, EASA, ITAR, DER, CAAC, NADCAP and others. Established metrics to monitor QMS effectiveness.Managing all quality and administrative functions associated with the fabrication, assembly, testing of the use of Micro Abrasive Technology for a myriad of applications: Medical, commercial Automotive, military and Space Electronics.Responsible for the quality administrative functions for the development processes in electronics, aerospace, precision machined components, medical manufacturing, and semiconductor technology, wafer manufacturing and fossil preparation.Providing management support for continuous improvement activities for receiving, in process and final inspection, in compliance with ISO 9001-2015, ISO 13485-2016 and MDSAP.Defining and documenting Quality Objectives associated with customer, client-based inputs, with regulatory compliance initiatives for the manufacturing and distribution of hardware applicable to the industry. From July 2017 to April 2020 (2 years 10 months) Glendale, California, United States