Quality Engineer Medical Device

Muhammad Sadeque

************@*****.*** 832-***-**** Raynham, MA 02767

Summary:

• Experienced, Innovative Research and Mechanical/Manufacturing Engineer.

• Expertise in Health Care, Heavy industrial process automation, Construction, Inspection, Manufacturing, assembly, repair, reliability, Project management, cost reduction, quality, safety, and continuous improvement.

• Known as a self-starting, result-oriented team player, driven by quality. Excellent communication skills. Areas of expertise Include:

• Development, Design, Manufacturing of Medical Device Quality CAPA Risk Management NC Audit Mechanical system component selection and sizing Process automation Engineering change order Compliance Conduct root cause investigations of mechanical equipment failures FMEA studies Project management P&ID drawings, designs Implemented continuous improvement program through lean manufacturing, Value stream mapping Six Sigma planning, scheduling, resource cost control initiatives.

Certification/License:

• Six sigma Black belt certification #138789956704713878995670471.

• Certified quality Engineer (42 hours) refresher Course Completed by ASQ Rhode Island, USA

• OSHA 10 hours Industrial Training

Training:

• J&J internal process training: Windchill, Adaptive, Agile, CDR

• GE internal process training: PLM, ECO/ECR, eF&O, VCC, configuration management, compliance, acoustic control

• GE Oil & Gas: Function & maintenance of gas metering equipment & instrument Computer Applications:

• MS Office (Word, Excel, MS Project, PowerPoint, Outlook)

• AutoCAD 2015, Solid works, 2013-2014

• Minitab

Professional Experience

Integra Life science (Full time), Mansfield, Massachusetts, USA Nov 2024-Present

Sr. Quality Engineer

• Nonconformance (NC) and Capa initiation, Evaluation, Investigation, review and close out.

• Product disposition/ Quality Control MRB activity including Product containment, release, Scrap and return to vendor (RTV) activity.

• FDA audit backroom support & response.

• Initiate and drive the product nonconformance (NC) globally

• Medical device manufacturing Process verification & Validation review and approval. (IQ, PQ, OQ, PFMEA, FAI, TMV, Attribute agreement & Control plan), Supplier Quality

• Experience with Medical device validation and Quality Management Process (QMS) including drafting and review of Protocols, Quality plan, SOP & Work instructions (WI)

• Train and certified operators in manufacturing, clean rooms. Johnson & Johnson (Contract), Raynham, Massachusetts, USA Oct 2018-Nov 2024

Quality Engineer/R&D Engineer

• Project lead. Prepared Medical Devices Risk management files, DFMEA, RMR, CAPA, NC’s, DHF and Declaration of Conformity (DOC).

• Support the remediation effort of MDR, BSI project to ensure all existing FMEA/risk documents are aligned to the new process. It covered detailed reviews and evaluation of many documents.

• Medical device manufacturing Process verification & Validation. (IQ, PQ, OQ, PFMEA, FAI, TMV, Gauge R&R&Control plan), Supplier Quality

Muhammad Sadeque

************@*****.*** 832-***-**** Raynham, MA 02767

• Experience with Medical device validation and Quality Management Process (QMS) including drafting and review of Protocols, test reports.

• Knowledge of the QSR, Design Controls, and ISO quality requirements.

• Strong ability of Blueprint reading/literacy including GD&T

• Project lead of non-CE blue, handling suppliers, stakeholders for drawings updates, documentation and material disposition.

• Worked EUMDR project of Claims, Verification & Validation& BSI Audit response.

• Project scheduling, Planning, and monitoring with effective use of project management tools.

• Lead and managed Offshore &Onsite team. Ensure all deliverables meet project milestone in effective way.

• Coordinate with cross functional teams including Engineering, quality, supply chain to achieve project goal.

BAKER HUGHES, A GE Oil and Gas Company, Houston, Texas Apr 2017 - Feb 2018, USA Engineering Project Leader/Manufacturing Engineer

• Lead SAP migration project for reconfiguration of multiple product bill of materials (BOMs) to develop new configuration logic for process automation.

• Shop, as build, manufacturing & Construction drawing& documents inspection & verification

• Prepared Engineering Change Orders with ECO/ECR process

• Management of database structures and data records for gas flow meters &instruments, AMR devices

• Supported business owners in analyzing data and build VC (Variant Configuration) for SAP migration project.

• Material coding & mapping for 20,000 parts as per UN code

• Created rule-based logic tools for use of SAP-VC operation.

• Created test plan, automation tools, manuals, specifications, drawing, presentation for factory. General Electric Company, GE POWER, Houston, Texas Jul 2014 - Mar 2017 USA Mechanical Engineer

• Project lead Provided technical support, development, Construction, Inspection of gas turbine package across the world. (TM2500, LM2500, LM6000, LMS100)

• Shop, as build, construction drawing &documents inspection, verification& validation.

• Worked with cross functional teams to get project deliverable on time basis.

• Interact vendor, suppliers, contractors to resolve technical issues.

• Managed Engineering change order (ECO)/Request (ECR) through PLM and maintained life cycle.

• Developed technical procedure, drawings(P&ID), Specifications for power generation package.

• Responsible for selection, sizing, assemblies, installation, maintenance of rotating industrial equipment and mechanical system components such as pump, motor, fan, cooler, flow meter, pressure/level transmitter, temperature sensor, valves, air filters, ventilation & combustion system.

• Root cause analysis, investigation of Mechanical failure and FMEA studied on design and development phase.

• Analysis reliability and maintenance data.

• Practiced ASME (Section VIII, Div 1, B31.1, B16.5), API, SEP, PED, ATEX, CSA, FM on DP product line components.

Education:

• Masters inMechanical engineering, CONCORDIA UNIVERSITY, Montreal, Canada 2012 – 2014

• BS in Mechanical Engineering, Khulna University of Engineering & Technology, Bangladesh, 1998-2002 Publications:

• Overview of medical device processing, Academic press, Elsevier

• Workstation Optimization by Lean manufacturing Technique-IJSEFT, A peer review Journal

• Risk management and sterilization process in Medical Device industry - GJAET, A peer review Journal

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