Patrick Curtiss

Experience

• 

  Rocky Mountain Composites Inc.

  Jan 2006 - Jan 2008

  Design Engineer

  • Designed 100+ flight control components for the Spectrum Independence and Freedom using SolidWorks (linkage and control surfaces for the aileron, aileron trim, flaps, rudder, rudder trim, elevator, and speed brakes) • Led project to design and build a test fixture demonstrating the aileron linkage for a General Electric investment meeting• Created 50+ detailed drawings

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  Novarad

  Jan 2009 - Jan 2012

  Regulatory & Compliance Manager

  • Establish and maintain Quality Management System (QMS) to conform to ISO 13485:2003, FDA 21 CFR Part 820, Canadian Medical Device Regulations SOR 98-282, CE Marking requirements (MDD 93/42/EEC and M5 Amendments), and HIPAA/HITECH requirements• Implement continuous improvement by correcting nonconformities, using root cause analysis, Pareto charts, process mapping, and corrective/preventive action procedures (CAPA) • Initiate teamwork between departments in order to prepare and pass annual audits• Identify strengths and weaknesses of processes and documentation (perform gap analysis)• Coordinate management quality efforts in 12 departments.• Author documents for the QMS including flowcharts, organizational charts, and procedures • Manage employees within the Regulatory & Compliance Department• Coordinate the establishment of Risk Management procedures using ISO 14971:2007• Train all new hires in regulatory requirements• Organize, lead, and direct management review meetings consisting of eleven department managers and report to executives• Led Novarad through: 4 ISO audits - 2009-2012 CE Marking certification opening a potential $14 million market in the UK – Completed June 2012  Meaningful Use Stage 1 EHR Module (ONC-ATCB) certification – July 2012 FDA comprehensive baseline audit - March 2010 5 internal auditsCompleted & passed RABQSA Certified ISO 13485 Lead Auditor Training - September 2009Novarad Employee of the Month - May 2010 Show less

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  BD

  Jan 2012 - Jan 2020

  • Execute department quality plan for automated production lines• Review and approve validation IQ/OQ/PQ protocols for multiple subassembly processes• Perform Measurement System Analysis (MSA)• Analyze and improve sampling plans• Lead site Behavior Based Quality (BBQ) team o Organize and direct monthly BBQ meetings consisting of seven department representativeso Report BBQ issues to Plant Leadership Team during monthly Critical to Quality meetingso Report Sandy Site BBQ improvements and status to corporate representatives monthlyo Organized and led the first annual Sandy site Quality Event in June 2017 • Create CAPA Initiation Determinations (CIDs), investigate root cause, determine appropriate corrections, and analyze effectiveness activities for CAPAs• Disposition and review root cause, correction, corrective action, sort/rework results, and final review for Quality Notifications (QN) • Implement and execute temporary deviations• Assess and approve department changes to tooling, software, and processes• Review and investigate customer complaints • Lead internal audits• Mentor and train Quality associates• Analyze and communicate critical department issues to plant leadership during management review Show less

  • Senior Quality Engineer

    Jan 2016 - Jan 2020

  • Quality Engineer II

    Jan 2012 - Jan 2016
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  Basic American Foods

  Jan 2020 - Jan 2022

  Quality Assurance Supervisor

  • Mentor and train QA Lab techs and production associates to improve plant quality• Quality lead for a plant improvement project to reduce waste and improve production• Review quality records including temps, weights, magnet checks, metal detection, micros, etc.• Perform tests for environmental monitoring, gluten testing, moisture content (calibrated moisture analyzers)• Perform periodic audits of the facility to ensure sanitation and GMP standards• Ensure compliance to SQF and FDA requirements in preparation for audits Show less

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  Spudnik Equipment Company LLC

  May 2023 - now

  Assembly Planner