Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Andrew Klumpp

East Leroy,MI

Summary

Effective quality professional with proven success in driving continuous improvement initiatives in various Quality Engineer capacities. Focused and diligent with commitment to ensuring corporate mission and team success. Consistently acknowledged for implementing actionable initiative to reduce error rates and optimize company processes.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Staff Advanced Quality Engineer

Stryker Instruments
03.2018 - 07.2023
  • Liaised between design, manufacturing, and program management as a contributor to the development of spinal catheter balloons, high speed drills.
  • Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues pre-market.
  • Maintained compliance with industry standards and regulatory compliance during managed projects.
  • Originated Application FMEA, reviewer and contributor to Process and Design FMEAs.
  • Human Factors expert within the Stryker VCF (Vertebral Compression Fracture) portfolio to solve design improvements to deliver best in class medical devices.
  • Conducted multiple Design Validation studies on cadaver specimens
  • Performed a transnasal/spinal high speed bur validation 8 months ahead of schedule (+$100K in project savings)
  • Supported Equipment and Performance Qualification of Plastic Injection Molding tools
  • Internal P&PC Quarterly auditor for High Speed Drill manufacturing lines
  • Production Part Approval Process (PPAP) Lead for High Speed Drill and VCF components
  • AQE Lead responsible for the commercial launch of three unique Vertibral Compression Fracture Device Portfolios (AVAFlex), Minimally Invasive Surgery high speed drills (MIS 2.0)
  • Contributed to root cause analysis to determine core reason for failures and errors to complete CAPA activities.
  • Validated ultrasonic measurement gages, implemented quality inspections and drafted reports to detail non-conforming material issues.

Senior Advanced Quality Engineer

Stryker Instruments
02.2015 - 03.2018
  • Pre-Market Quality engineering Lead on a first-to-market micro surgical handpiece portfolio
  • Performed safety risk analysis, and implement effective risk controls to address post-market CAPA findings.
  • Responsible for conducting failure investigations stemming from the products in the field, identification of potential failure modes and risks associated with them, and the resolving customer issues appropriately
  • Statistically developed the rationale for Design Validation/Human Factors sample size, duration, and number of locations based upon market use and Risk profile.
  • Review and approval of product and process change control documentation.

Advanced Quality Engineer

Stryker Instruments
07.2013 - 02.2015
  • Review and approval of design prints, GD&T application.
  • Author/Reviewer of requirement specification documentation, design history file reviews, and testing protocol requirements.
  • Develop statistical rationale for testing based on risk region identified through the FMEA process.

Test Engineer

Akebono Brake Corporation
03.2012 - 07.2013
  • Direct coordination with suppliers to ensure test protocols emulate real world scenarios
  • Managed multiple test programs within department, increasing efficiency and created a testing strategy plan that was utilized by Friction Material department to release K2XX platform Brakes, Caliper, and Rotors
  • Interacting and creating communication lines with technicians and customers to fulfill timing and testing goals
  • Coordinating incoming testing materials for various vehicle platforms
  • Matching test outsourcing schedules with customer needs to fulfill required deadlines\
  • Identified testing requirements of new to market non-asbestos carbonate treatment of rotors.
  • Overseeing test fixture builds for various vehicle platforms.

Test Technician (Contractor)

Stryker Instruments
05.2011 - 03.2012
  • Performed and documented multiple FDA Verification and Developmental test procedures as Lead technician in System 7 Collet and rotary surgical portfolio (S7)
  • Worked with R&D engineers to develop clear test methods and procedures prior to executing protocols
  • Identified key potential indicators of failures and proactively worked with R&D and Test Lab to queue up the next incremental product and reduce downtime
  • Setup and application of fixtures to fulfill testing requirements
  • Code logic and programming lead for Lithium Ion Battery testing fixture
  • High speed camera data acquisition and analysis.

Education

B.S - Mechanical Engineering Technology

Ferris State University

Skills

  • Best Practices and Standards
  • Internal Audit Coordination
  • Design and Manufacturing Reviews
  • International Regulatory Compliance
  • Risk Management and Mitigation
  • PPAP Submissions
  • Non-Conformance Processes
  • Incoming material Inspections
  • Non-Conformance Reports post quality inspections
  • Root Cause Identification and Analysis

Certification

ASME Y14.5M-1994 Certified Certified Quality Engineer, American Society for Quality

Timeline

Staff Advanced Quality Engineer

Stryker Instruments
03.2018 - 07.2023

Senior Advanced Quality Engineer

Stryker Instruments
02.2015 - 03.2018

Advanced Quality Engineer

Stryker Instruments
07.2013 - 02.2015

Test Engineer

Akebono Brake Corporation
03.2012 - 07.2013

Test Technician (Contractor)

Stryker Instruments
05.2011 - 03.2012

B.S - Mechanical Engineering Technology

Ferris State University

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Andrew Klumpp