Michael Heade Email & Phone Number

Quality Assurance Engineer and Regulatory Compliance Manager (Electronic Manufacturing) with strong Quality Engineering skillsets focused on supporting our communication products and driving product improvements for our customers.I mange the quality assurance management system here at Sonetics with additional responsibility for product regulatory and legal compliance. I also support production processes and recently set up lean manufacturing line for our Gen 3 products and increased productivity by 400%. Implemented ISO 9001 processes which resulted in cost and waste reductions and improvement and recently transitioned the corporate QMS to ISO 9001:2015 with zero nonconformities. I perform day to day management of the inspection team and work with suppliers to assure requirements are achieved. Implemented a lean and integrated Wiki based quality management system to further reduce overhead costs and drive efficiency of processes. I perform hands on work daily to address production issues, supply chain, contract review, compliance to customer and legal requirements and drive continual improvement.I support the design team with product qualification and physical testing of new designs, product and process improvement, design verification and validation regulatory compliance and reliability testing, change review as well as contract compliance and regulatory compliance to national and international standards (i.e.; FCC, CFR, NRTL, CSA, UL, EU, CE, IC, ANSI, MIL-STD, Export Compliance, FAR, ITAR, GSA...) I perform failure analysis on product returns from field, review service trends and work with Engineering staff to roll necessary changes and improvements through the ECO process to improve product reliability.

Hillsboro, Oregon, Us

Clean energy sector manufacturing of fuel cells. Responsible for production quality assurance at ClearEdge Power with focus on development, implimentation and continual improvement of production processes using APQC tools such as: PFMEA, Lean-Sigma, process control plans, supply chain quality excellence, risk analysis and risk reduction and employee training. Worked to control special processes related to fuel cell production which included AWS standardization, NDT and NDE of welds, and test and measurement of plating and coatings. Monitoring and measurement and improvement of product and processed using JMP and QI Macros software. Certified Lead Auditor of ClearEdge Power ISO 9001:2008 quality and ISO 14001 certified environmental management systems. IPC-610, IPC-620, J-STD-001, ANSI, NRTL...

QA Manager, Lead Auditor and Quality Engineering of Display Systems Division in Hillsboro, OR and control of off shore manufacturing facility in Suzhou China.•Supported implementation and maintenance of ISO 9001:2000 and AS9100B quality management systems.•Process improvements and continual improvement in production manufacturing areas which included drafting of process control plans and improvement of process control documentation which helped prevent and reduce product defects.•Assessed, restructured and improved supplier management processes, maintained compliance to customer flowed down ISO 13485 product configuration requirements.•Risk reduction, process qualification, monitoring supplier audit, closed loop corrective action. IPC-610, IPC-620, J-STD-001, ANSI, ESD compliance...•Used software such a Minitab, SQC Pack, QI Macros (Excel) to monitor, measure and improve product and processes.

Us

(Company previously owned by GN NetTest).Supplier Quality Engineer responsible for continual improvement in suppliers.• Maintained production area quality and continual improvement of the quality management system. • Lead ISO 9001 internal auditor and responsible for IQA FQA and MRB processes. • Insured compliance to safety and environmental laws as the safety and environmental compliance owner.

QA Engineer / Process Engineer – (PA & E Vancouver Division – Enhanced Flat Panel Displays and Electromechanical Components also formerly known as Electronic Specialty Corporation)• Quality and production process engineering, process improvement product validation testing, root cause and closed loop corrective action.• Testing and troubleshooting to component level and failure analysis.• Documented changes to existing processes to further support quality improvement. Worked with suppliers and customers to overcome quality issues and traveled to outside facilities to conduct supplier audits and validate product at suppliers.• Safety, regulatory and environmental coordinator for the Vancouver WA. facility, responsible for permits, training and compliance to state and federal laws