Quality Engineer Manager or Sr. QE
Resume:
D. Anthony Amaro, CQE
Long Beach, California 90808.
●**********@*****.***,
Operations, Quality and Supply Chain Management/Development expertise and Principal Plant CQE in Medical, Aerospace, Defense industry, Automotive and all AS9100, ISO9001, TS16949, ISO13485:2016, ISO14971:2012, NADCAP and ITAR environments
Summary
A versatile leader with over 30 years experience as strategic planner for meeting all critical to qualitly and COQ KPIs while achieving safety standards, and exceeding customer expectations. Implements FMEAs per customer specific requirements cross- functionally.
Areas of Expertise include :
CAPA / Fault Isolation
AS9100 / ISO 9000 / TS16949
Risk Mitigation/NPI
SPC/KPI analysis
NADCAP / ITAR/ ISO13485
Customer Satisfaction
Lean / Six Sigma
Supply Chain Development
RTV/RMA/MRM/ 8D
FMEA/APQP / PPAP
Policy/ Procedure Develop
Strategic Planning
World Class Experience
Medical Device - Sr. Technical Quality Consultant, March 2018 to present. (Contractor / Consultant)
Biosense Webster - a Johnson and Johnson Family Company, Irwindale and Irvine,
Cardiovascular & Specialty Solutions and Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of heart arrhythmia device Ablation Catheters manufacturer and neurological medical devices- Lead and support design verification tests, process validations, quality process procedures and achieve applicable external requirements and standards, including FDA, ISO 13485, and ISO 14971, CMDCAS, PMDA and other worldwide regulatory agencies including Environmental, Health & Safety practices, and other applicable standards as pertains to medical devices. Provides mentorship on complex problems, working independently to develop solutions for advanced integration strategies. Corrective Action/Preventive Action (CAPA) assignments and aiding in IQ, OQ, PQ & NPI validation verification.
●Direct Failure Mode and Effects Analysis activities for both Design and Process Failure Mode Analysis.
●Ensure that development activities follow design control requirements, product is tested per applicable standards, European requirements are met per the MDD, and product is properly transferred to manufacturing.
●IP, OP & QP specification development, and sampling plans.
●Support vendor audits as the leader as needed and support Supplier Quality representative as appropriate.
●Participate in MRB review of nonconforming product; recommend disposition and corrective action.
●Assist in escalations and field action analysis as appropriate.
●Performs Gap analysis and resolve concerns therein.
Business Team Quality Engineer (Contractor)
Parker Hannifin Aerospace, Military Business Unit. Irvine, CA August 2017 – February 2018
Assesses warranty and production quality performance ( cost-of-quality) using statistical and analytical methods. Devises and implements various methods and procedures for inspecting, testing, and evaluating precision, reliability, and accuracy of products, processes, and production equipment.
Develops and establishes advanced quality constraints and techniques, risk mitigation thru PFMEAs per customer specific requirements and performs supplier audits, authors procedures, inspection plans, quality performance trends, statistical plans, cost estimates, and technical plans for proposals. Ensures that project and/or process control documentation is compliant with requirements.
Assesses the cost of, and determines the responsibility for nonconforming materials, statistical controls while establishing confidence in setting sample sizes and acceptable errors.
Provides input on quality to product development teams; recommends improvements in process reviews, addresses technical data packages inaccuracies, manufacturing methods, equipment, tooling and training.
Operations and Manager of Quality Assurance / AS9100 Project Manager
Engineered Magnetics, Inc.,Inglewood, CA February 2016 to March 2017
Manages and directs all aspects of quality operations in tandem with manufacturing schedules, including supply chain management & development, SCAR, internal CAR, and all program metrics and key performance indicators. Resolving build problems and risk mitigation (PFMEA), procedures development, operator training in high reliability DOD cabling, modules products and components. including medical devices and equipment. Working closely with customers and DCMA reps. and closing out nonconformance items.
An accomplished AS9100 leader in preparing for registration audits – Trainer in internal process RC/CAPA using all the above and below tools and principles. Appointed interim Operation Manager of 35-40 employees. Certified ICP Specialist – J-Stds 001 Inspection 2016
Supplier Quality Project Manager: GE Aviation / Woodward HRT - Duarte, CA - June 2011 to Jan 2016
Plans and coordinates concerted team efforts using the above tools in 300+ suppliers for validation of CARs, quality audits and industrial readiness for process, programs and systemic audits. As an At Large contractor, duties similar to DCMA representation at supply sites regarding deliverables of machined, dye casted and fabricated parts. Conduct MRB, NCMR, gate reviews for PPAP and critical processes. Remedy compliance and corrective actions while mentoring teams for continuous improvement and training. Expert in TQM, PDCA, regulatory requirements in AS9100.
Quality Manager : Accurate Metal Fabricators, Inc. Anaheim, California 09/2006 to 6/2011
Managed ~75 employees in multiple facets of machine shop disciplines in a SPC driven metals/machine shop environment. Maintained ISO 9001 & AS9100 standards, developed startup policies, shop instructions, quality alerts, RMA, continuous improvements and problem resolutions. Ensure supply chain materials meet performance metrics (KPI). Customers include Haas, Motorola, Rapid Scan Ind., Bell, JCI; Visteon, Lockheed Martin.
Cost Reduction:
Streamlined workstations with boundary samples, quality alerts and build instructions/procedures. Champion of reduction of customer complaints from ~ 29 rejections per month to "0" in 3 months. Implemented quality culture change and continuous improvement programs. Cost savings of 250k.
Sr. Quality Engineer - General Motors, Detroit, MI 11/1994 - 06/2006
Responsible for coordinating the day-to-day activities of the quality assurance function on the plant floor, bridging customer requirements and build issues while supporting all plant quality activities. Ensuring products, processes at supplier facilities conform to GM standards. Responsible for electrical/cables, and mechanical assemblies in Seating, Interior Systems, Door Panels, Exterior Ornamentation, Instrumentation Panels, (Navigation, Information, Entertainment and Passenger Restraint Systems Medium Duty Truck and Luxury Car platforms... Heat Exchange components, Engine Power source (Battery), Transmissions / Powertrain and Chassis Suspension items. Additional Role as Gatekeeper of suppliers, audits, non-conformance issues and pre-prototype (PPAP) submissions.
Used Lean, 5-S, Taguchi – (DOE/SPC), Kaizen – Continuous Improvements, 8-D, 5–Whys, problem solving tools in a defect free environments.
Cost reduction: Automotive Instrumentation Panel Builds
● $1000.00 per day scrap eliminated by identifying tooling dimensional issue when model change over omitted critical to quality items in GD&T callouts regarding incorrect fasteners, shims and washers. Results: 400k cost recovery of 400K per year.
Quality - Engineer
Hewlett Packard Company, Corvallis, 1983 AND April/1990- November/1994
Responsibilities included overseeing supplier development and program implementation of technologies for semiconductor I/C fabrication medical components, sensors and instrumentation in cleanroom, class II and III environments. Development of process methodologies, checkpoints, work/inspection instructions, PFMEA, control plans, pre approval process validation and resolving supplier non conformances issues.
Quality Engineer - Lockheed (Skunk Works), Palmdale, CA 1983 - 4/1990
Overall quality support in U2R program processes, product, and program systems integrity. Supervise prototype tooling development, systems validation and regulatory compliance in Mil Spec requirements, FAA and support DCMA. Engineering and change management, CA/PA and coordination of specialized composites fabrication for landing gear actuators hydraulics, bomb bay release doors, ejection canopy and V/H Stabilizer. Tier 1 suppliers: Singer-Librascope, General Electric Aviation Engine Systems, General Dynamics, Inc; TRW, Cherry Textron and PRV/Arden Aerospace Engineering.
Military Service, Credentials and Certifications
Military Veteran, US Navy - Honorable Discharge
Certified ICP Specialist – J-Std 001 Inspection 2016
Master of Science – Industrial Engineering, Oregon State University, Corvallis, Oregon
Bachelor of Science - Industrial Engineering, Oregon State University, Corvallis, Oregon
Bachelor of Science - Bus. Administration, University of Phoenix - Fountain Valley, California Certified ~Quality Engineer - American Society for Quality, University of Michigan
Quality Management Systems - Lead Auditor Training, (RAB-QSA)
Design Validation Problem Resolution - (General Motors University)
Six Sigma Green Belt
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