Elzaki Ishag

Member Title: Manufacturing Engineering Systems/Quality Assurance Manager
Organization: EngiCare Systems





EngiCare Systems   MN US / Part Time                                                                                      May 2014     Current

Sr. Manufacturing Systems Engineer/ Program & Quality Manager

  • Lead the planning and implementation of project
  • Facilitate the definition of project scope, goals and deliverable
  • Develop full scale project plans, assemble and coordinate project staff
  • Manage project budget, project resource allocation, plan and schedule project timelines
  • Track project deliverable, provide direction and support to project team
  • Constantly monitor and report progress of the project to stakeholders
  • Project evaluation and assessment of results


Diversified Plastics Inc.                                                                                                            March 2016 – Dec 2018

Quality Manager

  • Overseen, define & update the DPI Quality Management System and Quality Plan to comply with the regulatory standards 21 CFR 820, ISO 13485 and ISO 9001
  • Evaluate, implement and improve a production and process control strategy to achieve quality management and plant objectives
  • Participate on material review board. Provide quality engineering support to product/process validation effort
  • Review and approve changes to the device master record.
  • Review and approve qualifications and validation protocols and results
  • Develop and approve strategic quality planning.
  • Provide appropriate oversight and direction to quality engineering projects.
  • Support continuous improvement processes
  • Oversee the vendor qualification and certification programs in collaboration.
  • Comply with all DPI quality policies, procedures and practices through consistent application of sound quality assurance principles
  • Comply with all local, state, federal and DPI safety regulations, policies and procedures.
  • Provide effective quality engineering leadership in teamwork development, effective communication and quick responses to customer needs
  • Build organization capability for quality engineering in the selection and mentoring of professionals.
  • Build a strong interactive, working and strategic relationship with DPI manufacturing, quality management and other staff
  • Function as primary respondent during FDA, ISO and other 3rd party audits and follow up on any action plans
  • Responsible for managing 4-7 associates

Coloplast US.                                                                                                                                  June 2014 – July 2015

Sr. Manufacturing Engineer (Contract)

  • Develops manufacturing processes by studying product requirements
  • Develops and execute process validations, conducts Gage R&R studies, performs DOE evaluations
  • Assists production areas on equipment and process problems
  • Develops machine specifications and manages outside vendors
  • Coordinates new product or process start-ups with all operational departments

ATMI-Bloomington, MN USA                                                                                             February 2012 – May 2014

Quality Engineer (Contract)

  • Developed, implements methods and procedures for disposition of discrepant material and devises
  • Root cause analysis and implementation of corrective action for process related concerns.
  • Supported the Quality Inspectors to ensure products and processes comply with QMS
  • Conducted audits, closing audit, audits finding reports, determine corrective and preventive actions.
  • Created and maintain company quality documentation, such as quality manuals, quality procedures
  • Responsible for continual improvement activities to enhance the quality system
  • Responsible for receiving inspection and continuous improvement of QA receiving inspection process
  • Worked with Manufacturing to solve daily quality concerns, reviews nonconforming, and disposition
  • Coordinated failure analysis on customer complaints and participate in resolving process issues
  • Performed Risk Analysis activities including Health Hazard Assessment, FMEA & PHA
  • Implemented Infinity QS Proficient, SPC software in production

Medtronic, Inc/ATS Medical Plymouth, MN                                                                                  Jan/2010-Feb/2012

Component Manufacturing

  • Perform validations (execute validations, measure validation parts)
  • Developing and validating (IQ/OQ/PQ) for machines
  • Setup and troubleshoot Micro-blaster, Profiler and Vibratory machine
  • Develop tooling/fixture to mistake proof processes and equipment
  • Lean & Six Sigma Black Belt – Manufacturing Engineer Project

Ev3 Plymouth, MN                                                                                                                                   Aug/2008-Dec/2009

Manufacturing Engineer, Extrusion (Contract)                

  • Performed quality and cost savings improvements utilizing lean and six sigma methodologies
  • Utilized FMEA within process development, and DHF updates per FDA
  • Consulted with Process Development Engineers to ensure design for manufacturing elements are incorporated into PDP activities
  • Developed plans to evaluate process repeatability and stability through equipment qualification and process validation. (IQ, OQ, PQ)
  • Designed and evaluates new and existing fixtures, equipment, test methods, specifications, layouts,
  • Performed process equipment validations and supporting Lean manufacturing environment

St. Jude Medical, MN                                                                                                                              Mar2003-Aug/2008 

Manufacturing Engineering Internship (2007-2008) & Extrusion Technician (2003-2007)

  • Wrote testing protocols, reports and proposed recommendations for product improvement
  • Designed device prototyping and equipment/fixture
  • Completed documentation of all projects and data entry
  • Strictly adhered to procedures, assembly methods, and records completion
  • Followed good manufacturing practices/ISO9001 and safety requirements on a consistent basis
  • Collect Statistical Process Control (SPC) data through process monitoring and inspection









University of St. Thomas, Twin Cities, MN                                                                                                     2011-May-2014

  • Master of Manufacturing Systems Engineering

University of Minnesota, Crookston, MN                                                                                                             2006-2008

  • Bachelor of Science – Manufacturing

University of St Thomas, Twin Cities, MN                                                                                                                      2011

  • Certified Lean and Six Sigma Green Belt & Mini Master-Project Management Professional (PMP)

Hennepin Tech College, Brooklyn Park, MN                                                                                                        2004-2006                                                               

  • Manufacturing Engineering Technology specialization in Plastics Injection Molding and Extrusion (Diploma-2-year program, similar to Associates Degree)


  • Society of Quality Engineer (SQE).
  • National Society of Black Engineers (NSBE)
  • English:  Native
  • French:   Full Professional proficiency
  • Arabic:   Native or bilingual proficiency


  • Master Degree level course in Applied Statistics and Probability for Engineers (Using Minitab)
  • Master level course in Strategic Quality Management
  • Trained to use Programmable Logic Controller (PLC) Allen Bradley SLC 500
  • Systems, Applications and Products (SAP) certified
  • ISO 13485:2016 Lead Auditor (TPECS) Certification
  • ISO 14971 Medical Device Risk Management Training
  • Certified Process Validation for Medical Devices Principles and Protocols