Quality Engineer Resume Example

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Jessica Claire
  • , , 100 Montgomery St. 10th Floor
  • H: (555) 432-1000
  • C:
  • Date of Birth:
  • India:
  • :
  • single:
Professional Summary

Experienced Quality Engineer in validating process, equipment performance and Medical device product quality complying to ISO and FDA standards. Constantly striving towards implementing Quality Management System and improve its effectiveness.

  • Good knowledge on ISO 13485, ISO 14971, ISO 11137-1, 21 CFR 820.
  • IPC 610A Certified.
  • Certified Internal Quality Auditor ISO 13485 and 21 CFR 820.
  • Well verse with Microsoft Office.
  • Good experience in Root cause analysis and CAPA.
  • Leadership skills and good team player.
  • Effective communication skills.
Work History
Quality Engineer, 08/2020 to Current
Ametek, Inc. Lancaster, PA,
  • Responsible in developing and documenting critical documents such as Work Instructions, Standard Operating Procedures and Manufacturing Process Instructions pertaining to ISO 13485, ISO 1137-1, 21 CFR 820 and cGMP compliance.
  • Supporting core team in sterilization factory which includes but not limited to Process Engineers, Automation Engineers, Manufacturing Engineers in designing the Process Flow Diagram in compliance with Quality Management Systems.
  • Design, develop and perform control run and engineering studies as per customer request in order to evaluate system performance and improve process control to comply with FDA regulations and ISO standards.
  • Responsible to develop, review and update important Quality tool like pFMEA as per ISO 14971 to predict potential risks to the process and system and mitigate it.
  • Identifying Critical to Quality Attributes (CQA) and Critical Process Parameters (CPPs) by monitoring process and process data to achieve control over the entire system, to help obtain the required yield while staying in compliance with standards.
  • Create and maintain product traceability and build records using Device History Records to ensure product is complying to ISO and FDA standards.
  • Directly responsible for initiating Non Conformance Material Report, for the non conforming material with reference to CQA and CPPs pre or post sterilization. And perform further investigation and evaluation with Material Review Board and Quality Manager.
  • Following the NCMR, Quality Engineer is responsible to drive actions like Root Cause Analysis and Corrective and Preventive Action(CAPA). And update the top management on the steps taken, along with an investigation report evaluating effectiveness of CAPA in compliance with standards.
  • Assist Automation and Manufacturing Engineers in executing DOE planned by the customer to determine optimal parameters for the system and the process by using statistical methods and regression models to derive key points.
  • Support Process and Validation Engineers in executing process validation and equipment validation activities like IQ, OQ and PQ by providing guidance on standards and regulations whenever needed.
  • Coach and monitor Quality Technician with regards to following the process as defined in Work Instructions for DHR compiling, reviewing and Good Documentation Practices (GDP).
Equipment Validation Engineer, 07/2019 to 08/2020
Harrow Health, Inc. New York City, NY,
  • Initiate and implement standards and new methods for incoming inspection, testing and performance evaluation of the equipment and parts.
  • Plans on sampling procedure and design and develop instructions for recording, reporting and evaluating Quality data to ensure the reliability.
  • Perform Gage R&R for the equipments, tools using Measurement System Analysis.
  • Develop and implement optimal procedure to disposition non conforming material and then investigate root cause and suggest corrective action.
  • Direct QA and QC that are involved in testing and analyzing the system or the equipment performance regarding specifications provided by the customer.
  • Lead the change control planning and executing procedure if change requested by customer.
  • Issue Quality Problem Reports and Quality Alerts prior to executing change control plan.
  • Assure data availability and integrity for all Quality related data.
  • Assists with preparing and reviewing documents for Quality audits.
Graduate Assistant/Student Employee, 01/2018 to 05/2019
University Of Bridgeport City, STATE,
  • Assisting faculties in their research by designing and creating a prototype with the aid of SolidWorks and various 3D printing softwares.
  • Assisting fellow students in the Additive manufacturing course on resolving issues about their respective projects and make design corrections before slicing the model.
  • Resolving issues related to material or 3D printers. Communicating with vendors for any non conformances about the material.
  • Using different slicing software line Makerbot, Cura, Simplify3D to achieve best output quality.
  • Attending meetings on future developments on 3D printing and representing the University for the Connecticut's first STEM on wheels program.
Master of Science: Mechanical Engineering, Expected in 05/2019
University of Bridgeport - Bridgeport, CT,
Bachelor of Engineering : Mechanical Engineering, Expected in 05/2016
Savitribai Phule Pune University - Pune, India,
Diploma: Mechanical Engineering, Expected in 01/2013
Maharashtra State Board of Technical Education - Pune, India,
English :
Full Professional:
Negotiated :
Hindi :
Native or Bilingual:
Negotiated :
Marathi :
Native or Bilingual:
Negotiated :

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Resume Overview

School Attended
  • University of Bridgeport
  • Savitribai Phule Pune University
  • Maharashtra State Board of Technical Education
Job Titles Held:
  • Quality Engineer
  • Equipment Validation Engineer
  • Graduate Assistant/Student Employee
  • Master of Science
  • Bachelor of Engineering
  • Diploma