Tim Holzschuh, Asq-Cqa Email & Phone Number

Littleton, Co, Us

Arvada, Colorado, United States

Golden, Colorado, United States

OEM Power Supply and Control Equipment

Greater Denver Area

● Defining companywide Quality KPI’s● Strengthening Supplier Quality Performance● Regulatory Affairs and Quality Management - ISO 9001, ISO 13485, AS9100 and FDA cGMP requirements● Business Development - Medical, Aerospace, Industrial, Automotive● Risk Management / Risk Assessment● Customer Satisfaction

Golden, Colorado

• Manage / establish / maintain compliance with FDA QSRs (cGMP, 21CFR820) (including establishing FDA communication/channels for compliance on medical device listings/classifications) • Face to face communication/interaction with the FDA (Site inspections / FDA 482, Training)• Mitigation/follow up of FDA issued inspection observations (FDA 483) • Corporate/Internal FDA Steering Committee Chairman• Quality Management Representative (9001/13485/820.20)• Oversee corporate quality related registrations and certifications • Manage/establish/maintain compliance with the EU market MDD 93/42/EEC directive, CE Mark and Canadian MDR • Manage/establish/maintain Design Services certification of ISO 9001, ISO 13485 requirements • Primary point of contact for all regulatory communication for Design Services (Incident reports, audits, registrations etc.) • Responsible for customer complaint system and customer complaint reports • Responsible for evaluating product failures and generating the evaluation report • Responsible for working with R&D and manufacturing to develop validation protocols, production processes, Risk Assessment, and final approval of design transfer into Mfg • Conduct internal audits, coordinate and manage external ISO audit schedules, correspondence and closing of findings • Ensure full compliance to medical device design controls (820.30)• Ensure full compliance of medical device labeling and advertising • Audit and oversee Design History Files during development of new medical products for FDA compliance • Technical support of customer regulatory submission activities (Premarket Notification 510(k), Premarket Approval, IDE) • Regulatory and quality technical resource for customers, internal business development / proposal development• Implementation of LEAN, 5S, Six Sigma and TQM philosophies• Design Services Leadership Team member, responsible for reviewing and establishing the company quality goals and “pursuit of excellence” each year

Colorado

Tim was appointed Quality Leader in November 2011 and has maintained ISO-13485 (Medical) and ISO-9001 certifications for the Creation Technologies Design Services business entity.His focus is supporting and regulating medical device Design History Files (DHF) ensuring compliance with the FDA and a successful 510(k) / PMA submission process.While with Creation Technologies, Tim has acquired his Total Quality Management (TQM) certification and Six Sigma Green Belt (CSSGB).

Colorado

Quality Manager of standards ISO 13485 and AS9100C

Colorado

Electrical Design Engineer of commercial, automotive, industrial and medical products. Hardware and Firmware development, project management, and technical writing.

Golden, Colorado

Thermal Barcode Printers● Analog/Power conversion circuit design for thermal barcode printers. Micro-controller hardware implementation. PCB design.● Firmware development for Microchip PIC micro-controller based circuitry.● Battery powered product development. Battery charger and analyzer design.● Regulatory mitigation of new and legacy products. ● Sustaining engineering and cost reduction efforts of legacy products.● Technician management responsibility.● Patent awarded for media gap detection circuitry.

Littleton, Colorado

● Test Engineering, hardware fixture development for product longevity testing. ● “Smart” Air Pump product manager. Hardware and Firmware design. ● Web based data collection/system monitor development. ● PCB design. ● Quality management.

Arvada, Colorado

● Test Engineering, hardware fixture design and maintenance. ● Software design for production testing and calibration of entire product line. ● Microwave moisture analyzer power supply development. ● Regulatory mitigation of new and legacy products. ● Management of technical personnel. ● Patent awarded for moisture analysis power regulation topology.

Ft. Collins, Colorado

● Switch Mode Power Supply design for pulse power applications. ● Pulse power switch bank development up to 1Megawatt. ● PCB layout● Production personnel training.

Ft. Collins, Colorado

● Design team member of high voltage and high current SMPS development. ● System service power supply development. ● Product debug and prototype construction. ● Component procurement. ● Production test fixture design.

Windsor, Colorado

2Yr Cert, Electrical Systems

Under Graduate Studies - Mathematics