Kandeel J. Email & Phone Number

Boston, Ma, Us

Waltham, Massachusetts, United States

Waltham, Massachusetts, United States

Responsibilities:❖Design Controls & Process Controls ❖Manage Team of 3 to 4 Quality Engineers❖Global Compliance for CE Mark/ UL listing ❖Design Verification and/ or Validation❖Global Regulatory Compliance Training ❖Installation Qualification (IQ), Performance Qualification (PQ), Operational Qualification (OQ)❖ Environmental Compliance for RoHS, REACH, WEEE and California Proposition- 65 ❖ Global Product & Process Change Control ❖Global Training and… Show more Responsibilities:❖Design Controls & Process Controls ❖Manage Team of 3 to 4 Quality Engineers❖Global Compliance for CE Mark/ UL listing ❖Design Verification and/ or Validation❖Global Regulatory Compliance Training ❖Installation Qualification (IQ), Performance Qualification (PQ), Operational Qualification (OQ)❖ Environmental Compliance for RoHS, REACH, WEEE and California Proposition- 65 ❖ Global Product & Process Change Control ❖Global Training and Development of Design and Development Procedures❖Quality Assurance of SOP, Batch Record/s (CPR/s), Raw Material Specifications (RM/s), Components Specifications (CS/s), Drawings (DWG/s)❖Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Product Release Test❖Quality Auditing for Suppliers and Internal Functional Areas❖Corrective Actions & Preventative Actions (CAPAs) ❖Global Project Management for GMP/ Non-GMP product launches❖Technical Project Leadership for compliance Project (post-launch)❖Planned/ Unplanned Deviation❖Root Cause Analysis ❖Design History Files ❖Process Improvements, Process Efficiency, Process Development ❖Automation of integrated systems Show less

Waltham, Massachusetts

Experience: ❖Successfully launched Single-Use ATF1, NGL Impact Protein A and SIUS Gamma closed cassettes in compliance with ISO 9001:2015. ❖Quality Assured Technical Transfer of Manufacturing of ValiChrom Chromatography columns from Ravensburg, Germany to Waltham, Massachusetts site. ❖Quality Assisted qualification of manufacturing cleanroom per ISO 14644.❖Performed a full incoming inspection gap analysis for SIUS Gamma and ATF Controllers. Completed three major Validations… Show more Experience: ❖Successfully launched Single-Use ATF1, NGL Impact Protein A and SIUS Gamma closed cassettes in compliance with ISO 9001:2015. ❖Quality Assured Technical Transfer of Manufacturing of ValiChrom Chromatography columns from Ravensburg, Germany to Waltham, Massachusetts site. ❖Quality Assisted qualification of manufacturing cleanroom per ISO 14644.❖Performed a full incoming inspection gap analysis for SIUS Gamma and ATF Controllers. Completed three major Validations for AKTA pure as a part of OPUS improvement project. ❖Fully conducted an Internal Audit (Marlborough Validation procedure)❖Conducted two Quality on Floor evaluations to ensure quality compliance❖Conducted 5+ Design Reviews including NGC, TFDF systems, OPUS, Protein A, Captive A HF, SIUS Gamma closed Casettes and SUATF1.❖Supported 40+ supplier qualifications ❖Successfully conducted 3 supplier on-site audits as an Enigneering SME and Assisting Auditor. ❖Released more than 75 ATF C24 and C46 controllers (FAT) and 30+ SUATF2 batches. ❖Performed a thorough Gap analysis on CE compliance of all product lines globally an identified requirements for CE compliance. ❖Assured Quality and Compliance of safety testing performed on ATF controller in compliance with Low Voltage Directive, EMC directive, UL, CSA, EU, RoHS, REACH, and WEEE directives. ❖Implemented (85%) a global Design Control procedure that is aligned with Stage-Gate model for efficient New Product Development. ❖Independently lead a robust and Agile process for releasing Beta/ Alpha and Prototype Units across global sites that enables a compliant, and valuable product feedback before launch for iterations. ❖ Quality Assured customer facing documents to ensure user safety such as User Guide, Regulatory Support File, Quick Start-up guide, and Installation guide.❖Trained 20+ employees per quarter on New Product Development, Risk assessment and FMEA (Process, Usability, Design). Show less

Greater Boston Area

Adjunct Professor for College Algebra and Trigonometry (MNS1001)

Bloomington, Indiana Area

• Implemented 100% verification processes in Manufacturing/Quality Control(QC) Specifications for products with non-conformances (NC) as per Cook Quality System Instructions• Coordinated with Production Engineers, CAPA Engineers, and Quality Assurance to implement risk controls • Performed process validation including Installation Qualification (IQ), Performance Qualification (PQ), Operational Qualification (OQ) and sterilization validations for Urological devicesu• Created… Show more • Implemented 100% verification processes in Manufacturing/Quality Control(QC) Specifications for products with non-conformances (NC) as per Cook Quality System Instructions• Coordinated with Production Engineers, CAPA Engineers, and Quality Assurance to implement risk controls • Performed process validation including Installation Qualification (IQ), Performance Qualification (PQ), Operational Qualification (OQ) and sterilization validations for Urological devicesu• Created Product and Incoming QC specifications for a capital equipment and a urology wire guide• Planned Mechanical (JIST3246), Environmental and Biocompatibility testing (ISO10993) for 510K submissions• Designed and developed full Design History Files (DHF) for a new urological stent product line• Developed design control traceability table, Design FMEA, Process FMEA, Usability FMEA, Clinical evidence Analysis (CEA) based on Design Input requirements (DIR) to mitigate associated patient risks• Supervised venders to implement process monitoring of supplied parts to ensure quality compliance • Submitted and implemented 3+ Change Requests (CR) to update fixtures, molds, machines, and tools• Managed and performed tests, documentation, and IFU changes needed to launch the first reusable COOK Holmium Laser Fiber that utilizes Sterrad sterilization technique to cover about 97% of the U.S market • Coordinated testing efforts for COOK Holmium laser fibers needed for Cook Rhapsody system launch in China• Submitted Cook Internal Patents for a tracheal device and got top priority among 20+ patents submitted• Assisted the back end of compiling information for audits from the FDA, CFDA, Health Canada and LRQA Show less

Stony Brook Chapter

 Proposed the highest budget proposal of $31,98 from undergraduate student government Organized outreach program for 10 middle school student to encourage the STEM associated professions for college among students from under-represented background Arranged largest Executive- Board of BMES Stony Brook Chapter ever by Involving 14 undergraduates to actively participate from Stony Brook BME department Managed Student-Faculty social events with the highest attendance of… Show more  Proposed the highest budget proposal of $31,98 from undergraduate student government Organized outreach program for 10 middle school student to encourage the STEM associated professions for college among students from under-represented background Arranged largest Executive- Board of BMES Stony Brook Chapter ever by Involving 14 undergraduates to actively participate from Stony Brook BME department Managed Student-Faculty social events with the highest attendance of underclassman from the BME department Initiated the Executive board awards night to recognize all Executive-board members for their great work for BME department of Stony Brook Show less

Stony Brook University

 Managed budget of $7200 from 3 different accounts Initiated and hosted first Pre-conference, Breakfast mixer and Industry Panel to help peers in professional development Presented the highest ever $325 budget for outreach activities for Countrywood primary care center Attempted to assist a new mentoring program to provide underclassman BME students with help with basic academic concerns  Initiated industry panel for Stony brook BMES chapter by collaborating with Society of… Show more  Managed budget of $7200 from 3 different accounts Initiated and hosted first Pre-conference, Breakfast mixer and Industry Panel to help peers in professional development Presented the highest ever $325 budget for outreach activities for Countrywood primary care center Attempted to assist a new mentoring program to provide underclassman BME students with help with basic academic concerns  Initiated industry panel for Stony brook BMES chapter by collaborating with Society of Hispanic Professional Engineers to help students build connection with industry professionals Hosted a Networking session for 12 companies and hosted 50 students Collaborated with Stony Brook Career center to organize a workshop for conference Preparation and educated 45 undergraduate students Show less

Stony Brook, Ny

1- Provide the conflict resolution and peer mediation to fellow students2- Enforce a studious, safe and socially engaging environment for 300+ residents3- Establish and lead social, education and diversity events for campus community4- Promote diversity of culture, ethnicity, gender by organizing various events in residence halls

Stony Brook, Ny

1. Code algorithms to precisely read the ultrasound graph and analyze it2. Construct MATLAB code that reads the ultrasound graph to give out precise results3. Used Shortest path algorithm to interpret while preserving the complexity of the graph4. Utilize data from subjects to interpret the Ultrasound graph to give out the final results

Stony Brook Ny

 Surveyed student all across residence halls to analyze the internet service to determine the functioning of routers Analyzed the preferences of students to improve the network service of associated with web networking and provided trouble shoot suggestions to the peers

Stony Brook, Ny

1- Designed floor plans using AUTOCAD and test the material to use2- Supervise, facilitate and inspect the construction sites to ensure quality control3- Plan renovation projects with contractors and ensure health and safety concerns

Created flow charts to improve the work flow among the engineering departmentAssisted planning Database with IT to expedite the documentation practicesSubmited Cook Internal patent for medical device to treat tracheal stenosis and recieved top priority among several designs

-Inspected and inventoried medical devices including ultrasound, BP monitors, Thermometers, Centrifuges and ECG machines of 40 medical facilities -Reported using Microsoft ACCESS database for inventory of about 110 medical facilities affiliated with North Shore Long Island Medical system

Brooklyn, Ny

1-Researched on incidence of melanoma skin cancer and its possible cure using stem cell2- Determined the future consequences and early diagnostics of Melanoma Skin Cancer 3- Analyzed statistical distribution of Melanoma around the globe

Bachelors Of Engineeering, B.E, Biomedical/Medical Engineering

Activities and Societies: National Society of Black Engineers, BioMedical Engineering Society, Society of Hispanic Professional Engineers.

Certificate, Certificate Of Quality Auditing Iso 9001:2015, Certified Quality Auditor

Project Management Professional Training, Project Management, Certificate

Personal And Professional Growth, Organizational Leadership, Certificate

Communication Training, Educational Leadership And Administration, General, Group Training

Bachelor'S Degree, Biomedical Engineering, Senior

Activities and Societies: Biomedical Engineering Society (Former Chapter President), National society of Black Engineers, Society.

Certificate, Datawise: A Collaborative Process Of Learning And Teaching, Certified Instructor

Activities and Societies: Harvard GSE3X An Introduction to DataWise: A collaborative process of Learning and Teaching

Certificate, Quality And Safety, Certified

PH555X: Improving Global Health: Focusing on Quality and Safety

Certificate, Certification

Leadership, Team-Building and Coaching Skill for Managers This course provides a thorough learning experience of leadership, skills.

Certification, Organizational Leadership, Certification

The Exceptional Team Leader: This course allows one to understand, learn and grow from skills that are essential in developing and growing.