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Click here or scroll down to respond to this candidateCandidate's Name
Street Address Highland CourtStreetsboro, Ohio Street Address
PHONE NUMBER AVAILABLEDear Sir or Madam,I have 30 years experience in manufacturing encompassing various leadership and Engineering roles including senior Management positions. My background and experience include Quality Management, Quality Engineering, Operations, Purchasing, Material Control, Production and Customer Service. I have experience with ISO 9001:2015, AS-9100, IATF 16949, ISO-13485:2016, Coast Guard C.F.R 46, SOLAS, military specifications, DCMA source inspections, FDA regulation CFR 820 for Medical Device Manufacturing and UL testing and inspections. I am proficient in areas of Quality, production, inventory control, ERP systems, financial planning, and development of Quality Management Systems. Processes which I have developed, implemented and have been directly responsible for include corrective actions, MRB and disposition non-conforming material, calibration, continual improvement, statistical methods, document control, validation of automated and manual processes, in-process and incoming inspection, APQP, PPAP, supplier quality, customer complaints, warranty reduction, and product testing. I have worked on cross functional new product designs teams from development through product launch to ensure all customer and quality requirements were identified following advanced product quality planning. I have experience working with manufacturing in transitioning from product design to production including, assembly line layout, development of in line check fixtures, and finial packaging including development, implementation and training of personnel on procedures and work instructions. My experience covers a wide range of industries and processes including light and heavy mechanical assembly, metal fabrication, welding, forming, power coating, plastics molding, electrical and electronic assembly and rubber extruding and molding. I am a certified Green Belt in Lean Six Sigma. I have led and participated Kaizen events to improve manufacturing efficiency and Quality and reduce rework and scrap through the use of Six Sigma and Lean Manufacturing methodologies. I have performed internal plant and external supplier audits to identify system deficiencies. My experience and background in manufacturing should qualify me as a successful candidate for this position. A copy of my resume is enclosed. I am available to discuss my background and experience with you at your convenience. My salary requirements are negotiable considering benefits, and the opportunity this position can offer. I feel that this position could be the opportunity that I am seeking. Sincerely,Mike AdlardCandidate's Name
9979 Highland CourtStreetsboro, Ohio 44241PHONE NUMBER AVAILABLEEmail: EMAIL AVAILABLEProfessional ExperienceQuality EngineerReuter-Stokes, a Baker Hughes business - Twinsburg, Ohio August 2022 - Present Reuter-Stokes designs and manufactures precise radiation measurement, nuclear reactor monitoring, UV flame detection, and downhole sensors for gas and oil directional drilling. Conducting internal audits to ISO-9001:2015 standard. Lead cross functional continuous improvement teams improving process, product Quality and efficiency. Responsible for leading Corrective Action teams conducting problem solving, documenting root causes and corrections and auditing follow up actions for closure. Quality support for day-to-day manufacturing process and product issues. Representing Quality in new product design development review process. Quality EngineerAlacriant - Streetsboro, Ohio May 2020 August 2022 Alacriant Inc. is a manufacturer of stamped and fabricated metal assemblies serving the commercial, defense, and aerospace industries and is ISO9001, AS9100, NADCAP, & ITAR certified. Process include laser cutting, forming, welding, and stamping. Responsible for customer PPAP level 3 submission per AIAG standards. Including coordinating internal manufacturing and outside supplier operations. Compiling all required and supporting documents for customer submission. Working with engineering and manufacturing during part development to meet customer requirements. Including developing inspection control plans, verifying all part dimensions, capabilities studies on key characteristics and final PPAP sample approval. Write work instructions, and inspection instructions for completed assemblies and fabricated components. Working with manufacturing, Engineering and Purchasing to correct nonconformances through process or equipment improvements. Preformed internal audits to Quality Management System standards as specified with AS9100. Responsible for the CAPA (corrective action) process for internally issued and customer and supplier corrective action requests including problem solving (i.e., 5 Why, Pareto Chart, Ishikawa fishbone or Six Sigma methodology), full root cause analysis, determination of permanent corrective actions, and implementation and follow-up using the 8D format.Quality Inspection Supervisor (Contract position)Norman Noble - Highland Heights, Ohio February 2020 May 2020 Norman Noble is a contract manufacture of micro machined components used in medical implants and aerospace applications. Managed a department of 35 Quality inspectors over 3 shifts including training in dimensional and visual inspections using OGP Smart Scope Vision Systems, Microscopes and automated CMMs Vision System. Coordinate with Operations for production requirements and shipping due dates to meet customer requirements Schedule, set priorities and assign jobs based on the workload for inspection department. Ensure that all inspection processes are fully compliant, auditable and meet all regulatory, customer and company requirements on incoming material, in-process and finial inspection. Ensures inspection department is compliant to 21CFR820 and ISO 13485:2016. Assist in root cause investigations to establish corrective action plans and implements corrective action and preventive action. Reviewed and approved receiving inspection requirements, sampling plans and documents related to QC testing and inspections. Created and updated inspection and testing methods as needed Engage with customers on nonconforming product and corrective actions in an 8D IATF format. Work with production, engineering, sales, and customers to determine root cause and the corrective actions. Quality Engineer (Contract position)HITACHI Healthcare Americas Twinsburg January 2020 February 2020 Collaborated with the Director of Quality to address corrective actions and close nonconformances identified during a third-party audit in preparation for a recertification audit. Created and updated Procedures and work instructions to comply with ISO-13485:2016 standards and FDA Current Good Manufacturing Practices (cGMP) for Medical Devices. Assisted in evaluating and closing customer complaints. Quality Engineer (Contract position)Stanley Black and Decker Engineered Fastening Highland Heights October 2018 October 2019 Stanley Black and Decker Assembly Technology is a custom builder of torque tools and controller units used in automotive and high-volume assembly manufacturing facilities. Managed the internal and external quality procedures and process related to non-conforming material, MRB dispositions, Returned Material Authorizations (RMA) and incoming inspection. Reported nonconforming material to the supplier and worked directly with suppliers to improve product quality, performance and reliability which reduced nonconforming material by 25%. Developed control plans for CNC precision machined parts for in-process, receiving, and finial product inspections. Working with Operations, Engineering, Customer Service and Sales to resolve manufacturing and customer reported issues. Representative for third-party audits including ISO, CSA and UL surveillance and recertification audits. Responsible for the Advanced Product Quality Planning (APQP) process to achieve production part approval (PPAP) for designated suppliers in support of new product launches. Verification and validation testing of products and processes to ensure they meet intended requirements and specifications. Evaluated future equipment requirements against current resources and created and plan for capital spending with two- year return on investment.Senior Quality EngineerDelta Systems Inc Streetsboro, Ohio February 2014 October 2017 Delta Systems designs and manufacturers electrical switches, LCD displays and electronic control units for the outdoor power equipment industry. Process includes plastic injected molding, metal stamping, PCB through hole and SMT manufacturing, wire harness assembly, wire termination and electronic and mechanical assemble and testing. Managed a department of 7 Quality Technicians over 3 shifts with responsibilities for product Quality including inspection, testing, and process audits for all manufacturing processes. Quality representative on new product development teams acting as a liaison between Quality, manufacturing and engineering following the AIAG APQP process including compiling supporting documentation. Quality responsibility for development of PFMEA, control plans, process flows with work instructions, gage R&R, in- process and finished assembly inspection and testing criteria to ensure customer requirements are met per contract, proper validation of equipment and molds through the use of the IQ, OQ and PQ and PPAP submission. Quality representative and primary contact for customer relations including customer complaints and field warranty disposition. Analyzed all product returns to determine root cause of the failure. Compiling product returns and warranty data and creating failure trends and financial impact reports. Using the information and working with Engineering and Operations successfully implemented process improvements reducing warranty costs by 70% in the first year for savings of $850K. Interface with Manufacturing, Product Development, Engineering, Sales, Purchasing and Marketing to assist with obtaining resolution to customer complaints and increase customer satisfaction. Managed and lead the CAPA (corrective action) process for internally issued and customer corrective action requests including problem solving (i.e., 5 Why, fishbone or Six Sigma methodology), full root cause analysis, determination of permanent corrective actions, and implementation and follow-up using the 8D format. Updated the Quality Management System to transition from ISO 9001:2008 to ISO 9001:2015 for certification Internal Lead Auditor for ISO 9001:2015 and ISO-13485 standards. ERP (IQMS) system implementation team (Quality Module) I resigned from Delta Systems in October of 2017 after 4 years of service to assist with my familys business and to be a caretaker for a family member.Quality ManagerDurox Strongsville, Ohio September 2013 February 2014 Durox manufactures rubber and silicone molded gaskets, seals, and rubber extrusions and other related components for Railway, Automotive tier-1 and aftermarket applications. Management Representative for compliance of the Quality Management System in all areas and for all processes related to ISO 9001:2008 and the Association of American Railroads Standards. Responsible for Rubber Testing Lab and maintaining A2LA certification including but not limited rheometer, tensile, specific gravity, compression and durometer. Involve with all areas of testing requirements and main contact for outside testing resources. Maintained regulatory compliance to REACH, RoHS and Conflict Minerals to meet environmental policies and procedures. Supervised 3 Quality inspectors responsible for auditing product and manufacturing processes. Quality ManagerHDT Global- Solon, Ohio February 2013 - September 2013 HDT manufactures industrial heaters, environmental control units (ECUs), power generators, chemical / biological / radiological / nuclear (CBRN) air filtration and collective protection systems for military, government, industrial, and commercial markets. Responsible as Management Representative for managing compliance of the Quality Management System in all areas and levels of the company including ISO 9001:2008, DCMA, and DLA Government Regulations. Reviewed new government contracts for Quality inspection requirements and the quality assurance surveillance plan. Quality ManagerSurvitec- Sharon Center, Ohio July 2012- January 2013 Survitec manufactures Inflatable rafts, fighter pilot anti G suits, and submarine escape suits. Management Representative for compliance of the Quality Management System including ISO 9001:2015, AS 9100, Coast Guard C.F.R 46, SOLAS, DCMA and DLA Government Regulations and contract requirements. Responsible for the Quality Management System for Sharon Center manufacturing facility and 2 uniform distribution centers located on USAF bases. Managed 2 Quality Engineers and 12 Quality Control Technicians including product durability testing, assembly, and inspection of finished good products. Maintained and managed the supply base for product Quality including product identification, design configuration, status and acceptance identification, and material traceability. Monitor the verification of suppliers process including special processes through Process flow diagrams, PFMEA Process Failure Mode Effect Analysis, Control plans, and Inspections plans with data. Verified material traceability for customer and regulatory requirements from raw material through all processing into finished goods utilizing certifications, unique identifiers, and testing documentation. Coordinate Quality Management System and Manufacturing Process Controls with parent companies in Northern Ireland and England. Manage development and implementation of new product designs and the transfer of technology from U.K. sister company to U.S. Manufacturing facilities. Management representative for all 3rd part audits of the Quality Management System. Conducted and organized all internal audits including auditor training Organizing and coordinating auditing procedures as per AS9100 standard Quality ManagerELBEX - Kent, Ohio November 2010-July 2012 Processes include custom silicon mixing and extrusion, rubber extrusion and secondary rubber splicing operations for automotive, construction and commercial applications. Responsible for maintaining compliance of the Quality Management System in all areas and levels of the company. Responsible for new product PPAP submissions including development of PFMEA, control plans, gage R&R, in- process and finished assembly inspection criteria to AIAG standards. Quality ManagerTrailer Component Manufacturing, Inc. Mentor, Ohio April 2009- November 2010 Trailer Component Manufacturing specializes in metal fabrication for the automotive and outdoor equipment market manufacturing snow and ice equipment, toolboxes, hydraulics, towing, truck and trailer hardware used in towing and commercial use. Processes include laser and plasma cutting, forming and fabrication, welding and assembly. Developed, Implemented and Obtain Certification of the Quality Management System to ISO 9001:2008 standard. Responsible for compliance of the Quality Management System for processes including metal fabrication, laser cutting, and punch press, manual and robotic welding, purchased components, and finial assembly of snow removal equipment. Development of control plans for refurbished, new manufactured and purchased parts. Including measurement techniques and test requirements and fixturing development. Quality Engineer IINational City Bank Operations Center Cleveland, Ohio November 2008 April 2009 Responsible for Process improvements with manual and automated systems used in check processing functions. Using Lean Manufacturing principals to improve production efficiency and Quality while reducing errors which impact customer accounts. Six Sigma Green Belt Certification through NCB in conjunction with ASQ. Quality / Manufacturing DirectorAdvanced Imaging Research Cleveland, Ohio August 2008 November 2008 Developed and maintained a Quality system to comply with ISO-13485:2003 standards and FDA Current Good Manufacturing Practices (cGMP) for Medical Device manufacturing. Wrote, implemented and, conducted training of procedures to all employees at all levels of the company on the Quality system. Responsible for all Manufacturing, Quality, and project management of Engineering projects to launch. Develop reports to benchmark Quality and track continuous improvement projects Responsible for Quality and FDA regulatory compliance requirements for medical device manufacture in from design to shipment of final product. Involved in new product design and development including verification and validation of the design, equipment, processes, and setting of specification. Analyze, investigate, and disposition all customer complaints and returned material in accordance with FDA regulations. Evaluate Vendors on their ability to meet Quality requirement through Second Party Audits as a Lead Auditor. Oversee the distribution and control of all released documentation used in manufacturing. Quality ManagerCommercial Turf Products (MTD) Streetsboro, Ohio September 1999 August 2008 Managed department of 20 people including quality engineering, ISO coordinator, Supplier Quality Engineer, Customer compliant handling department, product durability testing, and directed plant quality Supervisors and inspectors for a lawn equipment with annual sales of a $100 million per year. As member of senior management, I was responsible for profit and loss for plant operations to meet profit objectives. Develop a departmental budget based on projected sales including personal, capital spending, and department requirements including staffing and new equipment. Developed a Quality Management system compliant with ISO-9001:2008 for the manufacturing and distribution facilities. Responsible for Quality system that includes metal fabrication, welding, purchased components, and heavy assembly for commercial lawn care equipment. Work close with engineering, manufacturing, and purchasing to identify and improve manufacturing processes using Lean Manufacturing principals and quality tools. Helped develop and manage a testing program responsible for finished goods and component level testing of commercial lawn care equipment. Oversee the warranty process including reviewing claims, customer complaints, monitoring supplier charge backs and non-conformities and providing information exchange between CTP and our customers. Analysis the data providing feedback to engineering and management reducing warranty costs by 35% and increasing customer satisfaction. Manage a customer service group focused on customer satisfaction and resolving customer issues. Developed and implemented a training program for our customers field service technicians in the mower repair industry. Work with external sales force, Independent Retailers, and industry professionals on value innovation to understand the lawn care industry. Recruited, hired, supervised, and developed four Quality supervisors and one Quality Engineer, and responsible for a staff of approximately 30 associates. Developed and managed a system to ensure that suppliers and third-party suppliers meet the Quality standards and delivery schedules through audits and supplier rating system. Experienced in the use of Lean Manufacturing principles to drive continuous improvement throughout all areas of the business. Including leading over ten events and participating in over twenty in a three-year period improving processes and Quality standards through, value stream mapping, standard work, 6S systems and poka-yoke assembly operations. EDUCATION / TRAININGShainin Training for problem solvingBaker Hughes Internal Audit Training and Certification for ISO 9001:2015 Baker Hughes Problem Solving WorkshopCMM Zone3 3D Software and programingCMM Measure Mind 3D Software OGP Inc.Lean Six Sigma Green Belt Training and Certification Kent State UniversityTransition Training from ISO 9001:2008 to ISO 9001:2015 OMNEXFDA / ISO 13485 Internal Auditors TrainingDelta Systems Inc.Basic Metrology, Statistical Process Control (SPC), Gage R&R Delta Systems Inc.IPC-A-610 certification Acceptability of electronic Assemblies, IPC Specialist Delta Systems Inc. / Certified CIT TrainerESD Basics certificationDescoFundamentals of GD&T per ASME Y14.5-2009Effective Training Inc.Basic Calibration,American Society for Quality ControlMedical Device Lead Auditor TrainingStat-A-MatrixGMP 101 The Basics, GMP Beyond the Basics, GMP 820 The GMP InstituteProduction Part Approval Process (PPAP)American Society for Quality ControlStatistical Process ControlPolaris Career CenterAssociate Degree in Electronic Engineering Technology Electronic Technology Institute Cleveland Ohio |
