Management Quality
Resume:
BEN EDER
Toronto, ON
Cell: 647-***-****
*********@*****.***
OBJECTIVE
Quality and Manufacturing Manager and Organizational Excellence leader, involving proven skills of PLANNING, DIRECTING and CONTROLLING in an organization with national or international scope of manufacturing industry with specific focus on the Medical Devices Industry. QUALIFICATIONS AND BACKGROUND
20 years of progressive experience in
Directing at multiple management levels.
Planning, maintaining and improving the company's Quality Management System (ISO 9001:2000, ISO 13485 certified).
Organizing operational projects execution, process audits, corrective and preventive actions and cross-functional improvement teams.
Customizing and implementing Company’s ERP systems (SAP, Priority) . Controlling Company's Environmental and Health & Safety Management Systems. (OSHAS18001, ISO14001). ACHIEVEMENTS
BUILT, DEVELOPED, IMPLEMENTED and MAINTAINED the ISO 13485:2003 (Medical Device) Product Development and Manufacturing quality management system. Overall responsibility for external and internal audits, management reviews, SOPs, Work Instruction, etc..; responsible for Device Master Record Creation, Engineering Change Orders, and New Product Introductions; Overseeing company’s Corrective and Preventive action; Qualification and evaluation of vendors; Establishment of contract manufacturing quality plan Results: Company has fully implemented and maintained ISO 13485 Quality Management System which successfully supports large variety of medical device’s development and contract manufacturing activities . (FDA approved, Health Canada, CE).
BUILT, CONTROLLED and DIRECTED medical device contract manufacturing facility. Designed and implemented manufacturing processes; developed the company’s goals and objectives; Selected and hired employees; established Quality Management System; managed and controlled annual budgets; designed and implemented company’s ERP system; Implemented Continuous improvement techniques; managed Contract Manufacturing projects from transfer to manufacturing phase to mass production which included direct communication with customer, supplier and employees; Managed the company’s overall HR activities; Obtained responsibility for the company’s funding grant applications and submissions (SRED claims, employment, training and product development grants) . Results: Company’s medical device branch managed and manufactured more than 7 products for 7 different companies, generating revenues of more than 1 Million dollar per year. CONTROLLED and MANAGED Plastics extrusion manufacturing plants. Represented and activated the senior management strategic plan; developed the plants' goals and objectives; controlled 200 employees, two production plants, 8 production lines, grinders, packaging, warehouse, mixing plant, QA and maintenance; built the plants' annual budgets; supervised plant's managers decision regarding production plans, new machinery, personnel. Results: The plant managed successfully; the annual net profit -5 million USD. ORGANIZED the construction of Environment Health and Safety Management System. Formed the organizational structure of the new department; defined the department's goals, objectives tasks and responsibilities; organized and administrated the creation of the new plant's Environment, Health and safety department; initiated the accreditation process of OSHAS 18001 standard; advised and convinced the company's management to implement also standard ISO 14001 for Environmental Management System; executed training program for the entire company's employees. Results: The plants were successfully accredited for OSHAS 18001 and ISO 14001 standards less than a year from the project initiation.
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EXPERIENCE
DIRECTOR, QUALITY & MANUFACTURING
Kangaroo Group (Toronto)
K B T Contract Manufacturing Inc (KBT)
Kangaroo Design and Innovation Inc (KDI) 2009 - Present Built, controlled and directed the company’s contract manufacturing facility. Established manufacturing processes and methodologies; developed the company’s goals and objectives; Selected and hired employees; established Quality Management System; managed and controlled annual budgets. Designed and implemented the Company’s ISO 13485:2003 Quality Management System (Design and Manufacturing); Derived quality processes and procedures under 13485 certified environments. Achieved and maintained ISO 13485:2003 certification and FDA compliant. Customized, designed and implemented Company’s ERP system (Priority). Managed Kangaroo Design’s Product Development Project (Pediatric MR coil). Managed execution of manufacturing contracts, including overseeing and directing personnel. Handled the company’s HR department, including recruit of new employees, layoff and training. CONSULTANT, QUALITY ASSURANCE 2008 - 2009
Palram Americas
Evaluated and solved quality and technical issues, resolved long-standing process problems, and met operating, financial and quality objectives; directed new quality assurance manager in quality management subjects, Quality Control, organizational issues, customers and ISO standard maintenance; trained QA team in quality management subjects, procedures, regulations, process management and quality theories; assisted QA manager in ISO 9001:2000 maintenance; performed quality audits at site; administered the Canadian Construction Material Centre standard file construction (NRC-CNRC) and the Underwrites Laboratories (UL) products file maintenance ; planned and led improvement initiatives through the unification of specifications and work instructions. DIRECTOR, QUALITY ASSURANCE
Palram Ind. (1990) Ltd. 2006 - 2008
Controlled team to implement process changes to reengineer Company's Quality Management System; directed and defined the creation of the company's ERP Quality Management Module; developed a standardized and unified system of Company’s +5000 customers and +10,000 production versions; directed the construction of environmental and safety management system in the Company’s plants according to the ISO14001 and the OSHAS 18001 standards; executed the design and implementation of operation processes (production, material management and QC) project in the ERP (SAP) system in the Company’s new production plant in PA, USA; designed and planned the company's Knowledge management system.
PLANT MANAGER 2005 - 2006
Palram Israel
Paltough Israel
Directed the Company’s manufacturing plants in Israel producing PVC sheets, polycarbonate and extruded rigid PMMA.; supervised 200 employees, two production plants, 8 production lines, grinders, packaging, warehouse, mixing plant, QA and maintenance; controlled the plants’ operating budget of USD $15 million/year; supervised plant's managers decision regarding production plans, new machinery, personal, technology, QA and Environment and Health & Safety subjects.
MANAGER, QUALITY ASSURANCE 2003 - 2005
Palram Israel
Maintained overall accountability for quality management in the two plants including the certification of ISO9001:2000 standard and other national and international standards, QC performance, procedures management, You created this PDF from an application that is not licensed to print to novaPDF printer (http://www.novapdf.com) customer claims management, initiation of Material Review Board, raw material acceptance management, calibration, continual improvement initiatives and customer satisfaction evaluation; planned, defined and improved the company's customer complaint procedure; quality representative at the plant's management; initiated cross- training within production department; improved work flow and streamlined daily production; advised senior management on quality subjects and organizational excellence initiatives. QUALITY ASSURANCE ASSOCIATE 2002 - 2003
Palram Israel
Oversaw quality assurance for the plant manufacture of polycarbonate sheets, 3 production lines with outputs of 300 tons per month each; executed the maintenance of ISO9001:2000 standard, performance of internal audit plan, external authorization audits, document control, creation of procedures and work instruction, supplier performance evaluation, supplier approval and customer satisfaction surveys; activated out the organization’s move from ISO9002 standard certification to ISO9001:2000 standard certification; created a 150-page quality manual for the International Code Council (ICC); trained line operators with the performance of test specifications and procedure. TECHNICIAN, PRODUCTION & OPERATIONS 1997 - 2002
Paltough Ind Ltd
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EDUCATION AND ADVANCED TRAINING
CQE (Certified Quality Engineer) American Society for Quality 2009 CMQ/OE (Certified Manager of Quality) American Society for Quality 2008 BA in Economics, Specialization in Business Administration Israel 2002 Advanced training in:
ISO 9001:2000, OSHAS 18001, ISO 14001:2004 Internal Auditor
Quality management techniques: Lean manufacturing, Six sigma, Kaizen, TQM.
Management Principles
ADVANCED EXPERIENCE
Demonstrated ability as strong facilitator of organizational change. Extensive experience in medical device product development and manufacturing. Accomplished in the design, development and implementation of effective quality and operation-related training programs.
Excellent qualifications in cross-functional team leadership, resource management, operational planning and technical documentation.
Effective analytical/problem solving abilities with strong interpersonal and communication skills. Widely experienced in the plastics and Medical Device industries. OTHER
Open to business travel
SAP and PRIORITY ERP
References available on request
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