EXPERIENCE

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

EDUCATION

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)

MEMEBERSHIPS & LANGUAGES

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

ADDITIONAL SKILLS & CERTIFICATIONS

• 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