I manage and direct day to day operations for Supplier Quality, Quality Engineering, Receiving Inspection, Quality Control, Risk Management and Design Assurance.

▪ Directs team (Production, Planning, Customer Service, Equipment and Facility Maintenance) to meet corporate goals and objectives.▪ Routinely coordinated production activities to guarantee that all manufactured goods are produced in accordance with all applicable Medical Device, Quality and Regulatory guidelines.▪ Adapts production department scheduling to meet estimated ship date targets, environmental changes, and Marketing strategy objectives with a continuous effort to improve production performance and to meet ESD (shipment) goals.▪ Continuously builds on existing corporate training and development programs to continuously improve the manufacturing approaches of a world-class medical device manufacturer.▪ Collaborates with Marketing, Quality, Regulatory, Engineering and R&D teams to develop New Products in preparation for submission to regulatory agencies for review.▪ Updates the Production Master Plan in accordance with customer demand (orders).▪ Defines yearly productivity targets the production, Equipment Maintenance and Customer Service Department (Volume, Scrap rate, Productivity, Lead Time, and Customer Satisfaction) to achieve corporate goals and objectives.▪ Routinely monitors production indicators to identify loss of performance causes and launch action plans to reach expected level of performance.▪ Assists in the development of protocols and validation reports impacting the implementation of new equipment, materials, and processes.▪ Implements appropriate expense control measures in order not to exceed approved budgets

▪ Developed, implemented, communicated and maintained corporate quality procedures for all facilities in the US, China and UK. Maintained quality systems and policies in compliance with ISO 9001 requirements. ▪ Managed up to 17 direct reports in the US, China and the UK. ▪ Reduced monthly SCRAP levels from a monthly average of 22K to 5.5K.▪ Reduced global product failure complaint level from 180 open complaints to less than 30.▪ Reduced incoming inspection backlog from 150+ items per day to a less than 10 items per day average.

• Primary contact for Quality System Inspections with FDA and Notified Body (NSAI). Managed the complete quality system in accordance with ISO 13485. • Designed and executed the company's medical device product sterilization validation program (steam and EO annual re-qualifications) in compliance with applicable regulations.• Designed ISO class 8 and ISO class 7 manufacturing environments that were qualified as ISO 14644-1 compliant.• Designed the process for the validation of new medical device product offerings in accordance with FDA 21 CFR, part 820 requirements.• Identified and remedied negative process patterns by managing and trending the performance of CAPA, Deviation, MRB, Incoming Receiving, Final Packaging, Document Control and Calibration Programs.

• Managed the protocol development, execution and final reporting of sterilization validations (ETO, Dry Heat, and Irradiation) for all medical device products. • Provided trend analysis information for Sterilization, Environmental Monitoring and Calibration programs.• Key point person for quality system audits, FDA audits and Notified Body audits.• Redesigned and validated the RO/DI water and Ozonation systems, enabling the overall product yield to increase above 95%.• Developed in-house standards, identified items qualified for in-house monitoring and authored the necessary applicable procedures.

▪ Authored and executed equivalency, initial and retrospective EO validations/studies and reports using six-sigma evaluation methods.▪ Maintained facility procedure manuals and ensured compliance with applicable FDA, OSHA, and EPA requirements.▪ Management Representative for internal, customer, FDA, ISO (DNV) and other regulatory agencies during on-sight inspections with no 482 observations.▪ Led facility team for the annual Corporate Quality and Safety Systems audits resulting in 3.68 out of a possible 4.0 audit score.▪ Improved the overall Nonconformance rate from a 96.8% to 99.0% through effective implementation of 8D/5W corrective action methods.▪ Coordinated environmental monitoring and maintained EO personnel badge records for the facility EH&S program attaining 100% compliance.▪ Maintained calibration processes/records for all critical equipment for the facility.

• Authored and performed validations in accordance with steam (ANSI/AAMI/ISO 11134), ethylene oxide (ANSI/AAMI/ISO 11135) and Radiation; E-Beam (ANSI/AAMI/ISO 11137) sterilization guidelines, as well as, routine sterilization of all products.• Developed, qualified, and supervised the institution and maintenance of two deionized water systems (in accordance with The United States Pharmacopoeia, XXIII, 1995).• Coordinated routine water testing for all in-house water systems.• Assisted in installing and qualifying two GMP autoclaves which more than tripled load capacity reducing laboratory testing by 67%.• Utilized QSIT Audit processes and Corrective and Preventive Action (CAPA) systems to maintain and improve the company Quality System.• Assisted in maintaining documentation (MRB, LDD, and VCA) compliance within an ISO 9001(i.e., ISO 13485) environment.• Frequently utilized Kaye Instruments and Fluke validation systems and software to perform sterilization validations.• Performed routine batch record reviews and release for all routine sterilized products.