Quality Manager, Quality Engineer
Resume:
MEGANBECKER Williamsport *****, USA
****.*********@*****.***
PROFILE
Quality and process focused individual driven to safely and efficiently meeting production goals. Excels in dynamic leadership environments offering industry specific training and opportunities for strategic career growth. Embraces technological solutions to modern challenges. WORK EXPERIENCE
Quality Manager 03/2019 – 04/2020
SEKISUI KYDEX, Bloomsburg, USA
Directly supervised Quality Department technical and nontechnical staff Responsible for the UL and FAR regulatory compliance and certification of all products Championed the Quality Management System and contributed to it’s continued evolution Managed department budgeting, implemented cost saving measures Revised information systems to consolidate data repositories and decrease time loss due to excess touch points and redundancy
Decreased product warranty claims from 1.2% to .56% parts defective Established Supplier Quality program to test, monitor and improve raw material supply chain Developed and implemented RCCA procedures for cross-functional problem solving Published monthly, quarterly and annual A3 corporate reporting Quality Engineer III 03/2018 – 03/2019
ThermoFisher Scientific, Millersburg, USA
Compliance SME and author of Computer Software Validations (CSV)/Software Development Life Cycle programs
Validations lead and IQ/OQ/PQ author for all primary and auxiliary equipment, process, and cGMP systems
Streamlined cGMP process flows for increased effectiveness and compliance to regulations and guidelines
Investigated poor product performance and customer complaints for trends Lead improvement initiatives utilizing RCCA and process ownership Quality Engineer 10/2016 – 03/2018
First Quality Enterprises, McElhattan, USA
Developed and implemented risk-based procedures and test plans as needed to maintain fitness of the Quality Management System
Monitored test methods, equipment, and technician knowledge, skills and abilities through continuous needs assessment and R&R
Designed, commissioned and validated new gauges and test methods to streamline test methods and reduce tester variation
Conducted product performance and trend analysis to prioritize improvement initiatives and projects
Investigated nonconforming materials and product claims Interfaced with suppliers to reduce scrap and process interruptions issues due to poor performing raw materials and packaging supplies
Authored all IQ/OQ/PQ, CQV, and Change Control protocols for FQP McElhattan site Managed execution of protocols, analyzed data and reported process capability Quality Engineer 03/2015 – 10/2016
Plastipak Packaging, Havre de Grace, USA
Led Continuous Improvement Team for Sidel Blow Molding, Husky Injection Molding, Nissei Single Stage Blow Molding and Poly Extrusion Blow Molding Departments Exceptional decrease in defect PPM for Husky and Sidel by process and product optimization using SPC
Improved Ppk and Pp by limiting variation from machine process and eliminating tester error Led the Change Control program for all new machines, molds, resins, infrastructure changes and revisions
Led the Commissioning, Qualification, and Validation process for all new preforms, bottles, vision systems, leak detection equipment, inline and online metal detectors Matched customer expectation with product capability Collaborated with Engineers/Technical Experts to develop, revise, and implement procedures and training programs involving new and existing equipment Defined and monitored Statistical Process Control (SPC) for Sidel, Husky and Nissei critical parameters
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WORK EXPERIENCE
Quality Manager 11/2010 – 11/2014
Alpha Packaging, Saint Louis, USA
Directly supervised Quality Department staff and production personnel in cGMP facility Ensured the continued quality control in a 24/7 facility of 33 stretch injection blow mold and injection blow mold AOKI, JOMAR and UNILOY machines Responsible for the material acceptance and testing of HDPE, PET, PLA and PCR materials Developed and implemented training program resulting in 25% increase in employee retention Developed, implemented, and ensured the continued efficacy of the corporate HAACP plan Recordable customer complaints reduced to .15 complaints per million parts produced Focal point for communication between customers, engineers and sales Responsible for all quality control documents, policies and procedures Reported cost of quality metrics and utilized key performance indicators (KPIs) Performed NPD/NPT start-ups and evaluations
Nuclear Command, Control and Connmunications NCO 03/2000 – 11/2006 United States Air Force, Multiple, USA
Operated command, control, voice and data communication systems linking NC3 forces worldwide Managed and supervised critical positive control documents of nuclear triad forces Focal point for all operational communications issues involving connectivity to strategic forces Investigated, compiled and transmitted operational and situational reports to higher command EDUCATION
Information Systems Technology/Management 03/2000 – 11/2006 Community College of the Air Force, Maxwell AFB, USA English, Literature, Society and Politics 01/2007 – 06/2009 Webster University, Saint Louis, USA
SKILLS
Continuous Improvement
Statistical Process
Control
FMEA, DMAIC
Ishikawa, KAIZEN,
GEMBA
Process Capability
Analysis
Information Systems
Microsoft Office
SAP
iQMS
Sharepoint and
Powerapps
Trackwise
Made2Manage
Quantum SPC
Sales Force
CERTIFICATES
ISO 13485 Certified Lead Auditor Training
ISO 9001:2015 36-Hour Certified Lead Auditor
Six Sigma Green Belt Course
HOBBIES
Getting lost in
a good book
Nonprofit
Casual Biking
Continued
Learning
y
Market
Research
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