Summary
Overview
Work History
Education
Skills
Technical Experience
Timeline
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Shereen Daik

Darien,IL

Summary

Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance.

Overview

6
6
years of professional experience

Work History

Quality Manager

Medline Industries
09.2021 - 09.2023
  • Established and maintained robust Quality culture by overseeing compliance activities for Medical Devices, Drugs, Cosmetics, and Food sold into US, EU, Canada, Middle East, and Latin America
  • Lead total quality management system for Primary Care division by monitoring, trending, and leading continuous improvement projects for key Quality metrics and ensuring regulatory compliance
  • Managed team of engineers by providing technical mentorship, positive and constructive feedback, and implementing career development tracks to enhance their expertise and career projections
  • Developed and maintained procedures, work instructions, flowcharts, forms, templates, checklists, and other product and process-related documentation to ensure process compliance
  • Successfully implemented change initiatives to enhance process effectiveness and efficiency which lead to collective cost savings of over $150,000 annually
  • Lead and participated in internal and external audits, ensuring compliance with Medical Device QMS requirements, FDA CFR 21 820, and ISO 13485
  • Effectively communicated design controls, design verification and validation activities, production and process controls, CAPA, complaints, and risk management concepts across all levels of management
  • Managed complaint reduction programs designed to reduce and maintain complaints per 100K to be less than 0.25% across all product categories every quarter
  • Supported on-boarding and upkeep of over 150 suppliers globally
  • Created of technician team responsible for complaint handling and closure in order to streamline complaints across all divisions.
  • Updated quality control standards, methods, and procedures to meet compliance requirements as industry evolves.
  • Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
  • Evaluated employee performance and conveyed constructive feedback to improve skills.
  • Recruited, interviewed and hired employees and implemented mentoring program to promote positive feedback and engagement.

Quality Engineer

Medline Industries
09.2019 - 09.2021
  • Lead and managed projects related to launching and maintaining Medical Devices, Pharmaceuticals, Cosmetics, and Foods while maintaining quality compliance, timelines, and budgets
  • Designed, implemented, and executed Corporate Quality programs and initiatives to lower consumer complaints, improve manufacturing processes and practices, and establish new standards
  • Identified and implemented improvement opportunities to increase efficiency and effectiveness of Quality Management System
  • Completed root cause analysis using techniques such as 5-whys and fishbones to identify root cause of quality issues
  • Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA)
  • Supported in-process manufacturing activities such as validations, procedure reviews, batch record reviews, and created design history files and executed design transfers with contract manufacturers with internal and external customers
  • Created company-wide training program of relative quality topics directed towards product managers to bridge knowledge gaps between business personnel and compliance requirements

R&D Engineer

UOP Honeywell
08.2017 - 08.2019
  • Worked as part of a team in UOP’s EZPOP (Exploratory Proof of Principle) labs to design and/or configure pilot plants to prove the validity of upwards of 20 research proposals relating to the refinery, petrochemical, and gas processing industry submitted by UOP’s R&D Department
  • Simultaneously operated more than 7 projects in different pilot plants adjusting process conditions as necessary to deliver valuable results to prove/disprove proposed research theory prior to approving +1M dollar investments
  • Lead and engaged technicians to run remote pilot plants to achieve an R&D goal
  • This includes submitting initial test conditions and continuously updating conditions depending on results
  • Collected online data using PI Process Book and Chemlaunch, as well as submitted samples for offline gas and liquid product analysis
  • Calculated mass balances, conversion, selectivity, and yields and present data in clear and concise way.

Education

Bachelor’s of Science - Chemical Engineering -

University of Illinois At Chicago (UIC)
Chicago, IL
05.2017

Skills

  • Leadership and People Management
  • Analytical and Problem-Solving Abilities
  • Continuous Improvement
  • Cross-Functional Collaboration
  • Risk Mitigation
  • Change Management
  • Root Cause Analysis
  • Communication and Negotiation
  • Documentation Control
  • Compliance Monitoring
  • Regulatory Compliance
  • Supplier Relationship Management

Technical Experience

  • Quality Management Systems
  • Regulatory Compliance (FDA CFR 21 820, ISO 13485, and USP)
  • Project Management
  • Process Verification and Validation
  • Key Performance Metric Trending and Reporting
  • Complaint Reduction
  • Voice of Customer
  • CAPA & SCAR
  • Design History Files
  • Internal and External Audits
  • Supplier Quality
  • SAP
  • Tableau
  • Microsoft Office Suite

Timeline

Quality Manager

Medline Industries
09.2021 - 09.2023

Quality Engineer

Medline Industries
09.2019 - 09.2021

R&D Engineer

UOP Honeywell
08.2017 - 08.2019

Bachelor’s of Science - Chemical Engineering -

University of Illinois At Chicago (UIC)

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Shereen Daik