SUMMARY:

• QUALITY ASSURANCE MANAGER with over 16 years of experience in Manufacturing, Operations, and Production with background in Electronics and Electro - mechanical Industries, Manufacturing Procedures and Processes, Medical Equipment, Medical Devices, Electronic Circuits, and Pharmaceutical Packaging, Food Packaging, Safe Quality Food Institute (SQFI), Safe Quality Foods (SQF), Food and Drug Administration (FDA), US Department of Agriculture (USDA) Current Good Manufacturing Practices ( Confidential ), Hazard Analysis and Critical Control Points (HACCP), ISO Standards, Aerospace AS9100, 5S, Confidential Belt, Injection Molding and Wire Mesh Fabrication and Filtration. Certified SQF Practitioner, Certified HACCP, Certified SQF Auditor. Certified FMEA, CQE, ISO, AS Certified Auditor, Certified Verification & Validation, and SQF Board Committee Member.
• President, Vice President, Project Manager for ASQ 1345 Board and AAMI - Association for Advancement of Medical Instrumentation.
• Directing: People Management, Analyzing Information, Reporting Research Results, Technical Understanding, Promoting Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Dealing with Complexity, Problem Solving, Process Improvement
• SENIOR QUALITY ENGINEER/ MANUFACTURING ENGINEERING with over 16 years of experience in Manufacturing, Operations, Production, and Process and with background in Confidential Belt, Design of Experiments, Verification, Validation, Statistical Analysis, Electronics, Semiconductors devices, Sensors, Electronic Components, Electronic Circuits and Electro-mechanical Industries, Electronic Materials, HD Flexible Circuits, Electronic Components, Semiconductors Devices and Sensors, Thin Film Adhesive Tapes Abrasive Tapes, Electronics flat cable, tapes, bus bar, insulation, & Optical ITO Films, Roll to Roll Equipment Technology, Dry Off-Set Printing, Silk Screen, ORC Camera, Medical Equipment, Medical Devices, Injection Molding, Pharmaceutical Packaging, Pharmaceutical Cups /Lids, Food Packaging, Food Containers/Lids, and Wire Mesh Fabrication and Filtration. Medical Equipment include Respiratory Equipment, Physical Therapy, Cardiac Care Instruments, Surgical Instruments, Neurological Instruments, Pediatric - Cardiotocography (CTG), X-ray & MRI and Medical Device Registration (MDR). Strong analytical skills with understanding of global interactions.

STRENGTHS INCLUDE:

• Confidential Belt (Continuous Improvement)
• Statistical Analysis/ Interpret Analytical Data Associated with Product/Process Characteristics
• Direct Project/Program Management
• Manufacturing Procedures/Operations/ Processes
• Doe of Experiments (DOE) /Minitab 17
• Verification and Validation /SPC
• PFMEA, DFMEA, DMAIC, and Process Controls
• Define and Identify Product and Process Control Methods
• Identifying Critical Quality Attributes (CQA) and Critical Process Parameters (CCP)
• Direct & Support Process Development and Direct Formulation Improvement Initiatives
• Internal Process and Product Auditor / Inspections
• Corrective/Preventive Action
• Direct & Creative Problem Solver and Trouble Shooting
• Best Practice, QA Software, Auto Cad
• Develop Working Relationship With Internal and External Customers
• Quality Alerts, Safety Alerts
• FDA, USDA, ISO, AS, SQF, AS, SQF, HACCP, OSHA Regulation/Audits
• Analytical/Microbiology Lab Testing - Swabbing, Product Samples
• Pharmaceutical, Medical Equipment/Devices- Hospitals /Clinics
• Cert. Mgr. in SQF 7.2, HACCP, IOS 9001:2008
• Cert. Mgr. in ISO 9001:2015
• Cert. Mgr. ISO 13485-2003,ISO13485:2016, TS 16949:2002, ISO/IATF 16949, & ISO 9001:2015, ISO 1401:2004, AS9100
• Test Lab Equip, Dynisco Polymer Test, Oxy Sensor, pH Chemical Analyzer, Color Spectrum Analyzer, CMM
• Test Methodologies, CMM
• Device Master Record (DMR) and Medical Device Record (MDR), Device Master Record (DMR) and Medical Device Record (MDR), Unique Device Identification (UDI), End-of-Life (EOL), Shelf-life Plastics
• Direct Team Work Oriented, Team Building and Reward Recognition, Organizational Training
• Electronic Technology - HD Flexible Circuits, Optical ITO Films
• Electronic Components, circuits, Semiconductors Devices and Sensors,
• Testing Electronic Circuits Boards, Surface Mount Technology (SMT), Surface Mount Device (SMD), HD Flex Circuits, Components, Semiconductors, and Sensors, In-Circuit Test (ICT).
• Testing of First Articles with AQL Inspections.
• Clean Room 10,000, Automatic Optical Inspections (AOI), ORC Imaging Electronic Circuit Boards, Indium-Tin Oxide (ITO) Films, HD Flex Circuit Board Etching, Silk Screen, Chemicals, Aerospace AS9100 and Military Std.
• Plastic Injection Molding, Thermo-plastics/Plastisols
• Dry-off Set Print, Spray Painting
• Punch Presses, Stamping Presses, and Welding Presses, Kanban Lean Manufacturing
• Quality Testing New Product Development, PPAP, APQP, AQL, and Monitor PPM
• Leadership, Scorecard Development, Tracking and Reporting

PROFESSIONAL EXPERIENCE:

Confidential

Quality Assurance Manager

Responsibilities:

• Defines and directs manufacturing and facility utilization.
• Develops, maintains, and monitors a manufacturing budget
• Manages flow of product through scheduling and by adjusting hours and staffing.
• Oversees the production of parts to customer specification and within specific timeframes.
• Compiles, develops, and generates reports of manufacturing progress.
• Ensures compliance with manufacturing and safety procedures. Responds to emergencies in the manufacturing areas & facility.
• ISO 9001:2015 Certification. Continuously monitor the effectiveness of the management systems.
• Function as Lead Auditor for internal audits.
• Facilitates client, supplier, internal, and certification body audits.
• Manages and drives the Confidential processes.
• Facilitates internal metric reviews (trends, paretos, audits)
• Leads the development and improvement of a culture of quality, safety, and citizenship:
• Develops and drives behavioral expectations and reinforcement systems.
• Provides training and implementation leadership for:
• Quality of Management: IQMS, Policy deployment
• Design: Agile, QFD, Value engineering. Prevention: APQP, SPC, FMEA, MSA, PPAP, Verification & Validation Confidential: Kaizen, Root cause analysis.
• Manufacturing: 5S, theory of constraints, demand flow (DFT) Service Excellence: employee engagement, client surveys
• Responsible for supply chain quality management including supplier qualification, supplier on-boarding, defect prevention, quality management, and supplier improvement strategies. Responsible for ensuring the collection and analysis of client experience data, including warranty events, and implementing preventative action -
• Responsible for establishing product quality design and workmanship standards while ensuring their deployment. Understand and facilitate relevant industry standards for quality

Confidential

Quality Assurance Manager

Responsibilities:

• Savings of over $5,000,000 in Confidential defined improvements and Fail-Safes, Best Practice, and Kaizen Events.
• Scrap Reduction from 12 % to 4 % for a savings of $3M
• Managed process to improve operative KPI’s and reduce Cost (Six-Sigma & 5S), which contributed more than $1M to the bottom line.
• 80 % Reduction in Customer Complaints with a savings of $250,000.
• Direct and Managed Quality Assurance Department and Organization to strive for highest quality and customer satisfaction through strict management of company product specification program while adhering to company HACCP Program, FDA, USDA, ISO, OSHA, and SQF regulations.
• Direct in Lead Manufacturing efforts in specification of new manufacturing equipment, the acquisition of new equipment, and bringing the equipment on-line, Qualification of equipment.
• Performs daily monitoring activities on SQF programs including: Verification, Validation, Audit, SPC, Recordkeeping, etc. to ensure facility's continuous compliance with SQF 2000 code requirements
• Maintains and ensures all SQF policies, procedures, training manuals, logs, documentations, COAs, product specification sheets, and records up to date in meeting SQF Level 3 Certification requirements.
• Facilitates external audits on SQF annual recertification or other quality and food safety related 3rd party audits
• Managing Shelve Life Studies and Improve Safety of Products to Customers.
• Implementing Scorecards for Quality, Safety, and Production.
• Manage the Quality Engineers, Quality Technicians/Auditors and Quality Assurance Department activities of multiple functions. Managed 18 personnel in the Quality Department with bi-annual performance reviews.
• Implemented Internal Audits and Master Cleaning/ PMs into SharePoint for Continuous Improvement.
• Developed department(s) goals and objectives in line with company /business goals and priorities.
• Managed and implemented New Product Developing testing per customer specifications and FDA, USDA, ISO and SQF testing standards.

Sr. Quality Assurance Engineer/Manufacturing Engineer

Responsibilities:

• Ensure timely resolution of supplier failure, corrective actions and preventative actions ( Confidential ). Manage supplier performance and coordinate audits of suppliers.
• Direct & Manage multiple projects and tasks, from product inception through product launch.
• Oversee and support the overall quality activities of the plant that are related to the production environment including product/process/system non-conformances, root cause analysis, corrective/preventive actions ( Confidential ), manufacturing document changes, first article inspections, deviations, change requests, product hold, Production and Process Controls (PAPC) system compliance, and process improvements.
• Manage development teams in Failure Mode, Effects, and Criticality Analysis (FMECA), DFMEA, PFMEA, Design of Experiments (DOE), variation studies, and manufacturing process validations and production and process controls, PPAP, Quality Control Plan, and Quality Plans for New Product Development.
• Managed, Developed and Maintained Audits on ISO 13485-2003, TS 16949:2002, ISO9001:2004, ISO 1401:2004, AS9100 and SQF and HACCP.
• Develop First Article (Pilot) and Testing Electronic circuits, Electronic components, Semiconductors devices and sensors.
• Periodic material and product dispositions, failure analysis, and statistical analysis.
• Problem solving techniques - Cause Mapping (Why an incident occurred), Fault Tree Analysis, Five Whys, 7-Step 8 - D, Fish Bone Analysis, Confidential .
• Established experiments by applying full and fractional factorial techniques.
• Established sampling plans by applying attribute, variable, and sequential sampling methods.
• Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests.
• Established reports by collecting, analyzing, and summarizing data; making recommendations.

Quality Assurance Manager/Sr. Quality Engineer

Confidential

Responsibilities:

• Managed product development meetings and activity involving Quality System issues in US and International.
• Oversee and support the overall quality activities of the plant that are related to the production environment including product/process/system non-conformances, root cause analysis, corrective/preventive actions ( Confidential ), manufacturing document changes, first article inspections, production travelers, change requests, product hold orders, deviations, and PAPC system compliance Manage Confidential Projects by development teams in Failure Mode, Effects, and Criticality Analysis (FMECA), and FMEA, Design of Experiments (DOE), variation studies, and manufacturing process validations and Production and Process Controls (PPAP).
• New Product development using Confidential .
• Develop and document manufacturing procedures, training procedures, Engineering Change Orders, and Engineering Deviations.
• Implement and validate statistical process monitoring and / or control (SPC).
• Managed and implemented Value Stream Management.
• Manage Kanban Lean Manufacturing.
• Managed the Manufacture Quality Verification (MQV), VPI and VPC - APQP Manufacture Process Layout
• Problem solving techniques - Confidential, Cause Mapping (Why an incident occurred), Fault Tree Analysis, Five Whys, 7-Step, 8 - D, Fish Bone Analysis.
• Program CMM & VMM (Brown & Sharp measuring equipment) & Visual Statistical Process Control (VSPC).
• Utilize basic statistical tools (e.g., SPC, variation, stability, control) to analyze for trends or issues.
• Understand tolerances/specifications (e.g., layouts, gauges, blueprints) to determine compliance/capabilities
• Manage and support plant, product and process audits per ISO/TS 16949:2002, AS9100, and ISO 9001:2008.
• Verification and Validation in Punch Presses, Presses Welding, Filter, and Paint Lines.

Quality Assurance Manager/ Quality Engineer

Confidential

Responsibilities:

• Statistical Analysis, APQP, New product/process validation, design reviews and Safe Launch.
• Manage engineers in preparing Process Flow Diagrams, DFMEA, and PFMEA, Corrective/Preventive Actions & process trouble shooting and improvements.
• Manage, coordinate, review and submit PPAP documents to customer by p rovide direction in developing inspection plans, First Article Inspection, In-Process and Final Product Inspection, Sampling Plans, inspection and acceptance criteria and Design Validation Testing.
• Prepare Control Plans and conduct Process Capability and GR&R studies as part of PPAP submissions.

Quality Assurance/Operation Manager, Supervisor /Quality Technician/Engineer

Confidential

Responsibilities:

• Manage and support plant, product and process audits per ISO/TS 16949:2002, ISO 9001:2008, ISO1401-2004, AS9100, and ISO 13485.
• Manage 120 production operators in a clean room 10,000 environment.
• Coordinate, review and submit PPAP documents to customer and maintaining PPM.
• Electronic Components, Circuits, Semiconductors Devices and Sensors,
• Design and Test Electronic Circuits Boards, HD Flex Circuits, Components, Semiconductors and Sensors.
• Established Testing of First Articles with AQL Inspections.
• In-Circuit Test (ICT), Electrical Testing, Surface Mount Technology (SMT), Surface Mount Device (SMD).
• Developed manufacturing procedures, processes and training procedures.
• Experience in Chemicals, acids, lead-free solder, pH control, Confidential (RO), Deionized (DI) water.
• Responsible for the design and implementation of policies and procedures to ensure that quality standards are met during production. Oversees testing of processes and products.
• Verification, Validation, Statistical Methods, and Design Controls on circuit boards, chemicals, dry-offset.

Field Service Engineer

Confidential

Responsibilities:

• Identify and diagnose problems with little information remotely and on location.
• Problem-solving tasks may include resolving mechanical/software issues; resolving operating system bugs; and reinstalling software or hardware.
• Developed manufacturing procedures and training procedures.
• Repair and test circuit boards, test sensors, semiconductors devices, electronic components, and circuits.
• Schedule and perform preventative maintenance on machinery as required; report back on issues, orders and parts needed.
• And train customers on machine operations with optimum efficiency and managed and support ISO 13485.
• Install equipment including machines, software, and other accessories and Medical Devise Record (MDR).
• Prioritize and manage own travel schedule, visiting customers in designated region.
• Make sure machinery is in great working order and that the customers have designs and software updates as needed.
• Communicate effectively both internally and externally, utilizing a Customer Relationship Management (CRM) system to document actions and item performed, schedule future preventive maintenance needs, and other engineering functions.
• Meet all field service engineering metrics including on time preventative maintenance, hotline calls per region, support hours per region, uptime, and customer satisfaction.