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Manager Quality

Location:
Snoqualmie, WA, 98065
Posted:
November 07, 2016

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Resume:

Koross R. Hosieni

***** ** ***** **., **********, WA 98065

425-***-****, acxej3@r.postjobfree.com

WORK EXPERIENCE

Sr. Quality Manager, Flow International, Kent, WA, April 2016 to present

Responsible for all quality activities for all sites in North America.

Implement risk based assessment of customers’ needs and business requirements.

Develop statistical process control for all key characteristics of products and key process parameters.

Manage all activities for maintaining ISO 9001 certificate and start activities for obtaining AS9100 certificate.

Mentor and develop staff skills to ensure compliance with all internal and customer requirements.

Responsible for CMM inspections and calibration process.

Institute data driven initiatives for all key processes to effectively and efficiently eliminate all adverse results.

Develop metrics directly indicative of the health of the quality management system and take and assign proper corrective actions.

Develop and present reports to executive and team members.

Global Compliance Manager, Global Quality Assurance, Spacelabs, Snoqualmie, WA, July 2015 to April 2016

Accountable for all site audit activities (FDA, ISO Registrar, Notified Bodies, customer and internal audits).

Managed all aspects of Quality Management System in compliance with 21 CFR 820 and maintained ISO9001/13485 certificates for all sites.

Responsible for preparing audit responses and ensuring compliance.

Responsible for all Corrective and Preventive Actions (CAPA) activities for all sites.

Provided training for root cause analysis techniques.

Provided performance measurement metrics and trending analysis on various parameters.

Project manager for global compliance department. Managed activities of 3 consultants.

Provided weekly reports and analysis to the top executive and vice presidents.

Responded to all Management Corrective Action requests.

Developed plans and executed process improvements to enhance customer perception and improve product quality.

Performed Value Stream Mapping of various processes to ensure optimal flow of information and materials.

Promoted Lean Six Sigma tools and concepts to improve effectiveness and statistical rational & analysis.

Quality Assurance Manager, Zodiac Aerospace, Advanced Composites & Engineered Materials, Marysville, WA, September 2014 to July 2015.

Responsible for improvement of all elements of the Quality Management Systems (QMS).

Responsible for managing the AS9100 and NADCAP certificate for nondestructive inspections.

Responsible for a growing team of 120 plus members, consisting of 6 supervisors, one manager, 10 engineers, 5 administrative support, and 98 inspectors & operators.

Managed all aspects of the following departments and teams: Testing Laboratories, Final Inspection, Specification Review, Calibration, Quality Purchasing & Procurement, Receiving, Shipping & Packaging, Change Management, New Product & Equipment Qualification, First Article Inspection and Reports, Supplier Audits and Rating, and Data Analysis & Reporting.

Developed and implemented the Statistical Process Control (SPC) system for all Key Process Parameters (KPP) and product Key Characteristics (KC). Developed action plans for all adverse results and trends.

Developed operational metrics to measure and track performance throughout the site and establish baselines for all key processes and activities.

Managed ITAR compliance and activities.

Designated as Management Representative to customers, suppliers and regulatory agencies.

Promoted and implement operational activities in accordance with Design for Manufacturability (DfM).

Completed FAA annual audit with zero findings.

Quality Manager, MicroConnex Corporation, Snoqualmie, WA, May 2014 to September 2014

Managed all aspects of Quality Management System and maintained ISO9001/13485 certificates.

Managed quality inspectors and insured all customer requirements were adhered to.

Managed supplier activities and performed on-site audits.

Managed all lean projects and activities (Kaizen events, Value Stream Mapping, and 5S).

Developed the requirements for company wide data management and operational & financial metrics.

Managed corrective and preventive actions. Responded to customer inquiries.

Developed training curriculum and competency assessment for all operation and inspection processes.

Quality Assurance Manager, Terex Corp., Redmond, WA, September 2013 to May 2014

Managed all aspects of the Quality Management System and established best in class practices to improve customer satisfaction and perception.

Developed processes to effectively and efficiently address improvement in quality of products.

Developed lean strategies to improve quality and on time delivery while reducing cost by eliminating the sources of waste.

Collected the voice of the customer and developed plans to address customer needs and requirements.

Incorporated Six Sigma tools and methods to understand data and promote a culture of data driven decisions.

Conducted supplier audits and improved the quality of incoming materials.

Head of Quality, BMW/SGL Automotive Carbon Fibers, Moses Lake, WA, October 2010 to September 2013

Established industry best practices for quality and process improvement at startup and developed best in class processes for continuous manufacturing operation (support BMW i8 and i3 car models).

Managed and maintained ISO/TS 16949 Quality Management System.

Met with BMW board of directors and top executives on various occasions and presented technical reports.

Met presented with and presented the company’s positions to state and federal legislators on various issues, including transportation and green industry.

Managed all process improvement activities including training and mentoring of Six Sigma students.

Developed effective and efficient methods of collecting the voice of the customer for actionable processes to achieve highest customer satisfaction.

Established a testing laboratory with qualified personnel and state of the art instruments and equipment to produce results with a high level of accuracy, integrity and quality to deliver on-time results.

Developed effective relationships with all suppliers of raw materials through partnerships and clear communication of requirements.

Incorporated Six Sigma and Lean tools and concepts, in specific, Value Stream Mapping (VSM) of all major processes to eliminate waste and measure the flow of information and material through entire manufacturing processes.

Conducted supplier audits and visits to monitor and evaluate quality of material supplied and developed continuous quality improvement activities.

Developed metrics to accurately measure the quality of products and quality performance of all processes. Developed actions to proactively seek opportunities for preventive actions to eliminate risks for all processes.

Actively engaged in Problem Solving (8D), Design of Experiment (DOE), PPAP, APQP, Statistical Process Control (SPC), Design for Six Sigma (DFSS), Lean, 5S, and PFMEA.

Owner, Koross Consulting, September 2008 to September 2010

(Consulting firm offering tools and road map towards Operational Excellence)

Established a new business to address the special needs of clients in the area of Operational Excellence utilizing the Lean and Six Sigma approach to streamline processes.

Provided clients with cost effective and efficient strategies for meeting the higher demands of their customers for improving quality and reducing cost.

Met with clients and conducted gap analysis and laid a chart to measure the baseline, set business goals and establish milestones & timelines.

Proposed contract terms and assigned specialized resources to execute the plan.

Continually developed a talent pool of individuals offering various skills and competencies.

Quality Assurance Manager, Hexcel Composites, Salt Lake City, UT, February 2008 to September 2008

Responsible for maintaining the NADCAP, ISO 9001 and AS9100 certificates and managing the quality management system.

Managed projects for process improvement (Quality & On-Time Delivery) and oversaw change management activities by working and cross collaborating with individuals located in multiple sites.

Managed all customer complaints and served as the primary conduit for 300+ customers for the Voice of the Customer (VOC). Responsible for addressing complaints and developing effective solutions.

Mentored and developed a growing list of engineers in Statistical Process Control (SPC) and statistical modeling for improved capability for consistent and predictable products for advanced composite materials used in aerospace applications.

Point of contact for all prime aerospace customers providing various process and test data (SPC, Scorecards, etc.). Executed process improvement projects including creating charters, team member selection, progress reporting, timeline development, driving to achieve goals & milestones, and tracking project sustainability.

Managed the Material Review Board (MRB) and served as the focal point for deciding the final disposition of products in the areas of chemistry, mechanical and physical properties.

Managed corrective and preventive actions (CAPA). Developed metrics indicative of effectiveness and efficient methods to address customer needs and requirements in a timely manner.

Managed internal and supplier audit activities. Managed supplier quality activities within the purchasing department.

Six Sigma Program Manager/Quality Program Manager, Microsoft, Issaquah, WA, December 2005 to February 2008

As project manager, I obtained COPC Vendor Management Organization certificate for my organization.

Led Six Sigma projects for customer satisfaction improvement of commercial lines of business.

Established new quality programs for internal audits and corrective action processes to demonstrate and track compliance to COPC and ISO standards.

Developed, designed and maintained a comprehensive scorecard for the entire organization.

Implemented Statistical Process Control (SPC) tools to assess trends and compliance in meeting the set targets of the scorecard for each of the 12 lines of business.

Developed and implemented a corrective action process to solicit the root cause of deviation from the target or exhibited adverse trends of each of 500+ parameters on the scorecard.

Identified, quantified and prioritized key FY07/08 NACS improvement opportunities.

Led Lean/Six Sigma initiatives using value stream mapping of all NACS customers’ end-to-end experience to quantify operational, financial, and quality of service impact of all customer touch points.

Proposed and gained acceptance for developing a web based Virtual Agent to reduce cost and improve the quality of service.

Quality Assurance Manager, Hexcel Composites, Salt Lake City, UT, October 2003 to December 2005

Initiated zero-defect initiative groundwork with cross-collaboration for 3 U.S. and 2 European plants, achieving a sustained and measurable rate of defect reduction across the division.

Managed 40 direct reports and a $6 million annual operating budget.

Managed the Quality Assurance and Test Laboratory departments.

Issued certificate of analysis for all chemical (Chromatography, Thermo Analysis & Spectroscopy) and mechanical properties of delivered materials.

Performed Failure Mode and Effect Analysis (FMEA) for process, design and safety.

Oversaw all supplier quality activities and monitored the working environment and conditions, handling restricted materials, waste streams, risk abatement, labor relations, management retention/experience, capacity, capability and financial stability.

Improved supply chain distribution logistics by placing Kanban for outsourced suppliers to reduce the inventory on hand, reduce shortage, improve production scheduling and reduce material cost for production.

Developed material specifications and inspection plan for all purchased materials.

Oversaw quality management system (ISO9001 & AS9100) and conducted regular review of quality management system, made executive reports, drove action for continual improvement and ensured compliance with FAA regulations.

Implemented formal operational control program across two plants including process mapping and error proofing techniques for critical manufacturing and inspection steps, Statistical Process Control (SPC) and Gage Repeatability & Reproducibility. Improved operational control resulted in increased capability, reduced scrap rate, improved cost, increased customer satisfaction and became more competitive.

Change agent for identifying best practices, benchmarking with high performing operations and implementation of quality tools and concepts (Lean, Six Sigma, world class competitiveness, etc.). Improved corrective action and root cause analysis process to solicit lasting solutions.

Quality Assurance Manager/Six Sigma Black Belt, Toray Composites, Tacoma, WA, March 1997 to October 2003

Appointed as management representative to customers, suppliers and regulatory agencies.

Managed 20 direct reports and a $2.5 million annual operating budget.

Established basis for collecting the Voice of the Customer (VOC) data using QFD and Kano analysis to identify customers’ needs and requirements and devise methods for achieving them.

Maintained a zero-defect rate with no findings by customers and FAA for three consecutive years. Multiple recipient of Best Supplier of the year from The Boeing Company.

Cross-collaboration with sister plants in Europe and Japan for establishing unified quality management systems and compliance with standard registrars & regulatory agencies.

Established Quality Management System (ISO9001) and Aerospace Quality Standard (AS9100) from the ground up in record time.

Coordinated and leveraged best practices and lessons learned at other sites and regions to improve quality and cost.

Conducted regular review of quality management system, made executive reports and drove action for continual improvement.

Developed contract terms for suppliers of materials and subcomponents to include right of entry, change process approval, process control requirements and operator trainings.

Developed comprehensive internal Standard Operating Procedures (SOP) with extensive utilization of error proofing techniques.

Developed product specifications and institutionalized operational control measures to achieve near zero-defect.

Implemented Six Sigma concepts, Design of Experiment (DOE), 5S and Statistical Process Control (SPC) in manufacturing practices. Led continuous improvement activities throughout the site.

Provided in-house training for Green Belts and mentoring of new Black Belts.

Managed supplier audits, supplier rating, subcontractor activities and prepared contracts.

Chaired the Material Review Board and an active member of the Safety Committee.

Major contributor in winning the $18 Billion sole source contract from The Boeing Company (single largest contract ever awarded in civil aviation).

Chemist, Boeing Defense & Space Group, Quality Assurance, Kent, WA, May 1991 to September 1996

Designed a math model to predict material properties based on limited test data and improved inspection cycle time for received materials and subcomponents.

Improved work flow by utilizing automated and unattended methods of analysis (auto-samplers, robotics and software/hardware optimization)

Performed a variety of complex material characterizations of electronics, composites and polymer materials using HPLC, LC/MS, GC, GC/MS, FTIR, FTIR/MS, TGA, TMA, DMA, & DSC.

Implemented Statistical Process Control (SPC) and Design of Experiment (DOE) for improved operational control and optimization of processes.

Reduced test cycles from weeks to days in critical applications, resulting in improved workflow.

Scientist/Visiting Scientist, CIBA-GEIGY Corp., Ardsley, NY, November 1988 to April 1991

Major contributor to the team that launched first drug ever to sell more than $1 billion in one year.

Prepared documentation for new drug application with FDA.

Assigned to foster academic and industry collaboration to advance new and novel test methods at the University of Washington, Medicinal Chemistry department as a visiting scientist.

Responsible for developing new test methods using robotics and automated testing techniques.

Gave presentations on projects and relevant current technology and conducted original research.

Developed and installed new chromatography test methods for large scale testing of clinical samples.

Developed new test methods using Super Critical Fluid Chromatography and Extraction (SFC/SFE) to optimize separation and reduce thermal degradation.

EDUCATION

M.S. in Analytical Chemistry, Bowling Green State University, Bowling Green, Ohio

B.S. in Chemistry, Montana State University, Bozeman, Montana

Six Sigma Black Belt, Certified by GE Aircraft Engines, Cincinnati, Ohio

Certified COPC Coordinator, Vendor Management Organizations

Certified ISO Auditor

PERSONAL

U.S. Citizen, active in team sports



Contact this candidate