Alan Rea Email & Phone Number

Pittsburgh, Pa, Us

In charge of Quality Assurance for Howmet Aerospace Simi Valley site and responsible for the following:Quality Management Systems (QMS), Post Market Surveillance, Supplier Development, Quality Engineering, Management: Systems and Processes, Risk Management, Regulatory, CAPA, MRB, Data Collection/Reporting and Processing Lean Six Sigma-Continuous Improvement programs and processes, and Process Controls. AS9100D, and meeting AS13100, and AS9145:2016 requirements.

Brea, California, Us

In charge of Quality Assurance for four different sites for the Beckman Coulter Urine Analysis Business Unit: Medical Device Instrument Quality (Miami, Fl. facility), Chemical reagents (Carlsbad, Ca. facility-oversight for Urine Analysis products), and the Urine Analysis Chemistry analyte strips (Marburg Germany), and Chemical Reagents (Krefeld Germany).Hosted FDA audits for Beckman Coulter, Team Leader for our Reliability Team, Supplier Development, Reliability Engineering, Quality Engineering, Management: Systems and Processes, Risk Management, Regulatory, Post Market Surveillance, Data Collection/Reporting and Processing Lean Six Sigma-Continuous Improvement programs and processes, Process Validation-IQ, OQ, PQ, Design Controls and Process Controls, Quality Management Systems (QMS) implementation: ISO-13485:2016, MDSAP AU P0002.004, Current Good Manufacturing Processes (cGMP) 21 CFR Part 211 and 21 CFR Part 820, 803, 806, 21 CFR part 11, Good Laboratory Practices (GLP Handbook), Risk Assessments ISO14971:2019, IEC 62304:2015, IEEE 730-2014, ISO-27001:2022, IEC 62366–1:2015, IVDR (EU) 2017/746 and MDR (EU) 2017/745.Responsible for New Product Development Quality (NPD): Medical Devices for Urine Analysis, Hematology and Life Sciences: including Flow Analyzers and Reflectance Analyte Analysis, and Spectral Cytometer System (Laser Analyzers and Analysis), and Automated end-to-end Sample Preparation Systems-that includes: Specimen Wash, Lysis, Staining, and on-board Liquid Antibody Analysis. In addition, the development of the NPI Reagents: Multipeak Fluorospheres 8 color dyes polystyrene beads (small molecule synthetics) for cellular applications (e.g., lysed human blood, peripheral blood mononuclear cells; 40+ color panels for higher complexity cell analysis.), Nano-Sizing polystyrene beads for particle reference size analysis, and QC Controls, and Calibrators, Buffers, Flow and Diluent and Wash solutions.

Medical Device: Electronic, Mechanical and Electro/Mechanical; Class I, II and IIIRisk Management and Risk Assessments: ISO-14971:2012, IEC 60601Process Validation-DQ, IQ, OQ, PQ and CQ, and Process ControlsQuality Management Systems (QMS) implementation: ISO-13485, 21 CFR Part 820 Quality System Regulations for Medical Devices, and ISO-9001RABQSA Lead Auditor; ISO-13485:2003, and ISO-9001:2008 CAPA, Mgmt Review, Regulatory Processes; MDR, 510(K)/PMASupplier Development, Reliability Engineering, Quality Engineering, System Engineering: Hardware, Software and Firmware and V&V testing, and Failure AnalysisManagement: System and Processes, Data Collection/Reporting and ProcessingLean Six Sigma-Continuous Improvement programs and processes

Design and Develop and Manufacture of Thermal Printers for Medical Device Applications, Voting, Gaming and Specialty Thermal Printer applications.Responsibilities includes; ISO-9001 QMS Implementation, including data capture and reporting processes, training, supplier development, qualification testing (V&V) hardware & software, reliability test programs, manufacturing quality, design and validate product and test equipment, regulatory and compliance, lean sigma program, lean mfg. processes, design assurance and risk assessment program, design review and development processes and customer satisfaction programs. Accomplishments includes; Implemented and standardized our ISO-9001 Quality Management System at our design center and at our manufacturing facilities achieving ISO-9001 certification within 3 months! Created our Engineering integrated Design Review and our Design Assurance processes that is preventing quality issues up-front and allowing for more robust designs and improved the manufacturability of our parts and products. Implemented our Lean Sigma program within our operations and design processes; reducing waste, improving efficiencies and quality. Establish a world-class test lab with environmental testing, software and firmware validation, and creating design specifications for our products and test equipment and failure analysis processes and program. Supplier Development program- program includes process validations (DQ/IQ/OQ/PQ), conducting ISO-9001/ISO-13485 external supplier audits as a lead auditor and business review meetings improving supplier quality management systems process controls and reducing waste and preventing problems. Customer Satisfaction Program: Customer Training, Survey's-Assessments and Analysis process, Customer Satisfaction Opportunities review and development meetings.

Minneapolis, Mn, Us

Responsibilities includes; worked with implantable and external insulin pumps and glucose sensors, transmitters and monitors. I was involved with and participated on teams for; Process Validations (DQ/IQ/OQ/PQ), New Product Development and Introductions (including Class II and Class III Devices requiring 510(K) FDA product submission and approvals), and Product Transfers program and processes, and our Supplier Development processes. In addition, responsibilities included our Receiving Inspection functions and MRB processes. All processes are conducted in an ISO-13485:2003 and FDA regulatory environment-21 CFR Part 820 Quality System Regulations for Medical Devices (Class II and Class III devices). Accomplishments includes; I helped create our enhanced "Design Review Processes" and our "Product Transfer Processes" through helping develop a formal review and checklist process. Created and implemented our "Paperless Data Collection and Reporting Process" (21 CFR Part 11 compliant): First Article Inspection, Supplier Corrective Action, eNCMR-nonconformance material data collection and reporting processes (with dashboard). Created our World-Class Supplier Development Program that was rated as number one throughout all of Medtronic and was being leveraged by other Medtronic facilities- this program included supplier QMS and Process control audits to ISO-13485:2003 as a lead auditor. In addition, I was involved with implementing our Receiving Inspection "Real-time Data Collection and Analysis program". I was part of our new product development team that was responsible for our largest new product launch in the past 3 years; new "Glucose Sensor Transmitter" product; that I contributed and helped successfully launch.

Lincolnshire, Il, Us

Implemented World-Class Quality Management Systems (QMS) ISO-9001 QMS at 5 different facilities. Created “Global Data Capture and Reporting Systems” databases and “paperless systems”: CAPA processes, Supplier Performance, Receiving Inspection processes, Production Yields, Trend Analysis, Field Performance, Failure Analysis, Reliability Programs, Customer Satisfaction & Cost of Poor Quality Programs. Supplier Development Program-World-Class; SPC, supplier assessments, supplier training, Mistake-Proofing, process validations (DQ/IQ/OQ/PQ) and capability assessments, process control plans, MSA and PPAP.Six Sigma Improvement Programs-Lead several Teams implement “Six Sigma” programs to reduce waste, costs and improve quality and efficiencies; including Quality and Six Sigma Tools; PDCA, DMAIC, Mistake-Proofing, Prevention Processes. Established 4 World-Class Test Lab’s for Bar Code printers, Card printers and Mobile printers. Lead and created Design Verification and Validation Testing for Electro-Mechanical Card and Bar Code Printers, including Hardware, software, Firmware, RFID, and RF Radio (802.11, Bluetooth, etc.), and CE and UL testing.Reliability Programs and Design Assurance-HALT and HASS, Limits Testing, Reliability Predication and MTBF programs-ORT and Life Testing. In addtion, DOE, Design for X programs: Design for Manufacturing, Design for Testability, Design Margin, and Risk Analysis Program, DFSS, FMEA, and Design Tolerance Analysis program. Product Transfer Program-Successfully moved our Mobile Printer Manufacturing. Training programs-Created and taught several training programs to our associates, suppliers and customers, in addition to leading companywide Technology Symposiums (Media, Printhead, RF communication and testing).Regulatory and Compliance & Environmental Management Programs-RoHS, WEEE and other environmental initiatives. Implemented company Customer Satisfaction Programs. Lead successful implementation of “Lean Manufacturing”.

Rochester, New York, Us

Responsible for Product DVT/Qualification Testing, ORT programs, Supplier development, MRB, CCB, Contract Review, and process control related to Electro-Mechanical Devices "Telemetry" Tape Drives (Analog and Digital) for aerospace and military applications. Used MIL and NASA standards for creating test and inspection plans. I supervised inspectors and technicians conducting testing and inspections. I was a Customer interface that worked with customers such as NASA, the Navy, Government-DCAS; and other military and aerospace contractors. Operated in a MIL9858A QMS and Complied with the Boeing QMS AS-9000.

Mba, Business

Bs Business

Certification Of Completion Marketing, Marketing

Certificate Of Completion Business, Business

As Electronics Engineering, Electronics

Education record