Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Training
Timeline
Generic

Mohammad Rizwan Qamar

Jacksonville,FL

Summary

Experienced quality leader with over 15 years in the medical device industry, including key roles at Fortune 500 companies such as Medtronic and Boston Scientific. Expert in Quality Management Systems (QMS), regulatory compliance, problem-solving and cross-functional leadership. Proven track record of managing and developing large, high-performing quality teams (30–40 employees), including Quality Engineers, In-Process and Incoming QA, Calibration Lab, Quality Systems, and Document Control functions in Fortune 500 companies like Medtronic. Committed to driving continuous improvement, operational excellence, and regulatory readiness across global quality operations.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Sr. Director Global Quality

Next Science
01.2022 - Current
  • Maintenance of quality system and ensuring that activities performed are in compliance with quality manual documentation and associated procedures.
  • Successfully managed FDA & Notified Body for FDA Inspections, MDSAP/ISO 13485 and EUMDR audits.
  • Conduct Management Reviews with CEO and other business leaders to ensure effectiveness of QMS system.
  • Manage and oversee Domestic and International Contract Manufacturers for the business.
  • Successfully developed Quality Teams that can perform sustaining quality activities to keep the business running.
  • Deployed Continuous improvement activity program and established Quality culture committee to enhance quality processes and transform company culture.
  • Optimized project timelines by effectively delegating tasks and prioritizing workload among team members.
  • Developed strong relationships with key industry partners, fostering collaboration and mutual growth opportunities.
  • Cultivated a culture of innovation by promoting creative thinking and encouraging employees to take calculated risks in pursuit of solutions.
  • Managed risk effectively by identifying potential threats, developing contingency plans, and implementing mitigation strategies in line with overall business objectives.

Manager, Manufacturing Quality Engineering

Medtronic ENT Operations (Capital & Disposables)
01.2017 - 12.2021
  • Responsible for 30 Direct Reports which includes 5 Quality Engineers, 11 Quality Techs and 12 Quality Inspectors at Incoming and 2 Calibration Technicians.
  • Responsible for Operations Quality for two Manufacturing Floors (Capital and Disposables).
  • Well versed with CFR 820 and ISO regulations for Class I, II and III medical devices.
  • Responsible for key metrics related with JAX operations with respect to Field Corrective Actions (FCA), Product Hold (PHO), Mfg. related complaints and CAPAs and Non-Conforming Reports (NCMRs).
  • Reduced overall NCMRs for the site by 30% Year over Year.
  • Improved overall Mfg. Related Complaint Metrics from last Fiscal Year.
  • Significantly improved Ops Quality Culture and Engagement Scores compared to last Fiscal Year.
  • Successfully completed MDSAP and FDA Audits for the JAX site. Served as Audit Facing person for Operations Quality.
  • Created Plans and Roadmaps for all of Ops Quality Departments and created specific Goals and Objectives for all departments.
  • Established new metrics for Incoming Quality (Turn Around Time) and Calibration Group (Assets Calibrated, due, late) and improved Calibration Impact Report template and SOP.
  • Managed headcounts and budget for entire Ops Quality Group. Recruited multiple Quality Engineers and Quality Assurance Technicians (contractors and full-time).

Principal Quality Engineer

Medtronic
07.2016 - 12.2016
  • Executed Procedural changes to Validation Procedures to ensure effective and compliant IQ/OQ/PQ was executed on manufacturing lines.
  • Performed large scale training to Procedural changes, updates and new procedures.
  • Mentored Associate Level Quality Engineers and provided training on Manufacturing and Compliance related procedures.
  • Served as a champion and coach to variety of different DRM and DMAIC Green Belt Projects.
  • Served as Quality Representative for UDI (Unique Device Identifier) team to allow adequate labeling of GTIN/UPN, inclusive of direct marking, on both Capital and Disposable product.
  • Served as Quality Representative for Cost Savings Projects on Product Transfers.

Senior Quality Engineer

Medtronic
11.2014 - 04.2016
  • Complaint Transfer Assignment: Led complaint transfer of new product (Sophono) into Medtronic Quality Management Systems as a special assignment. Successfully completed transfer in timely manner and streamlined existing processes to accommodate complaint handling to be performed in Jacksonville facility.
  • Performed product training on Sophono for the entire JAX PQE team.
  • Completed multiple change and improve projects that are measured against quality and cost metrics.
  • Executed Process (PQ, PPQ), Operational (OQ) and Installation (IQ) qualifications on design and manufacturing changes made on existing/legacy products that stemmed from customer complaints or Non-Conformance Material Reports.
  • Performed Gage R&R studies to qualify test methods.
  • Used statistical tools (Minitab) to generate detail reliability analysis on products.
  • Engaged with Failure Analysis Team to participate in Root Cause Analysis and identify possible solutions.
  • Led multiple CAPAs generated from product failures (NCMRs) or customer complaints.
  • Performed detail complaint trend investigations for Capital Equipment that trip monthly complaint trend triggers.

Senior Quality Engineer

Medtronic
04.2014 - 11.2014
  • Managed all NCMRs (Non-Conformance Material Reports) for Capital Equipment. Performed proper containment, disposition and investigation activities.
  • Executed Corrective Action activities and implemented solutions on the manufacturing floor to enhance current manufacturing processes and controls.
  • In-depth knowledge of SAP to perform and execute NCMR tasks.
  • Supported Capital Service and Repair for all Quality related issues and Kaizen events.

Senior Quality Engineer

Medtronic
12.2012 - 04.2014
  • Managed all complaints for Disposables Product Families by performing detailed product analysis and conducting individual investigations on high level complaints files.
  • Provided detail technical product analysis on returned devices and developed failure analysis reports.
  • Initiated Product Holds and addressed Manufacturing, Design and Supplier related root causes in timely manner.
  • Used GCH (Global Handling System) system and provided key input on interface enhancements during application improvement activity.
  • Accurate and compliant complaint investigations on High level complaint files. Perform detail investigation to determine most likely root cause and further escalation of individual complaint.
  • Used Electrical Engineering skillset to assist with root cause analysis / investigations.
  • Participated in developing complaint process mapping, complaint process flow chart and developing robust complaint trending system.
  • Participated and provided key input in generating Reportability Guidance document for Capital and Disposables Products.
  • In-Depth knowledge of Regulations CFR820/CFR803/ISO 13485.
  • Interfaced with Internal and Corporate Auditors to highlight key escalation processes from Complaints to Product Investigation, CAPA and SCARs.
  • Updated and developed Risk Management Reports and assessed risk and occurrence ratings for individual complaint file.
  • Perform Product Investigations for product families that trip monthly trend limits.
  • Complete understanding and wide application of technical principles, theories, and concepts in the field.
  • Evaluate and approve ECN (engineering change number) changes for existing products, monitor design developments for maintaining quality compliance and assist in engineering testing and validation.
  • Establish and conduct a Failure Analysis Process to ensure Field Returns and Internal Product Failures are investigated to determine the root cause of the product deficiency.

Quality Engineer II

Boston Scientific Corporation
05.2012 - 11.2012
  • Assuming responsibility of Quality Engineering role for three endoscopy production lines.
  • Leading / supporting CAPA (Corrective and Preventive Action) work for all three production lines.
  • Addressing all manufacturing related complaints with appropriate / robust corrective and preventive actions utilizing statistical analysis and quality tools.
  • Approver for all re-certification activities performed as per required Design Verification Protocols.
  • Presenting all Quality Incidents to Senior Management and associated corrective / preventive actions against all related Quality Incidents.
  • Timely completion of all Non-Conforming Event Prevention Reports (NCEP) with robust corrective actions which includes implementation of new / additional controls, improvement in equipment and/or existing process flows.
  • Assess and initiate Product Inquiry Reports (PIR) for issues related with possible product recalls.
  • Collaborate with regulatory and clinical for completion of Product Inquiry Reports.

Quality Engineer II

Boston Scientific Corporation
12.2009 - 05.2012
  • Perform laboratory testing of product complaint devices according to Investigation Action Plan established by Complaint Investigators to assist in complaint investigations.
  • Systematic and quality oriented approach to determining root cause analysis on all complaint devices which includes return and non-return.
  • Thorough understanding of Boston Scientific product devices from Urology, Endoscopy and PI departments.
  • Responsible for providing detail investigation to senior management for all manufacturing related complaint and respective root cause analysis.
  • Write/submit reports in Trackwise (TW) GCS2 system for Complaint Investigations, escalating complaints to different functional groups as necessary.
  • Provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
  • Lead group and project teamwork; project and process improvements. Lead VIP (Value Improvement Projects) to improve complaint lab work flow.
  • Approval/Reviewer/Collaborator designee for various product / complaint related documentations.
  • Timely closure of complaint investigations (within 45 day period) in the GCS2 system.
  • Interface with R&D, value stream engineers (operations), product development engineers, supplier quality and other functional groups including CMC (Complaint Management Center) for appropriate analysis of each individual complaint to determine most appropriate root cause.
  • Compile and present complaint trending data to senior management, remedial actions on non-conforming events and updating monthly manufacturing/design related issues derived from complaint investigations.
  • Support product audits to ensure compliance for complaint investigations performed.
  • Thorough understanding of product recalls (Product Inquiry Reports) that can impact complaint investigation.
  • Perform other duties as requested by managers to support Product Complaint activities.

Quality Engineer

Boston Scientific Corporation
04.2007 - 12.2009
  • Proactively investigated and analyzed manufacturing related complaints to reduce complaint rate.
  • Sound knowledge of Trackwise (TW) GCS2 System (Global Complaint System), fluent in viewing and searching complaints for product families.
  • Monitor complaint trends and data (CAL limit trip and adverse trends) in order to escalate emerging issues appropriately.
  • Sound knowledge of Product functionality and risks associated clinically and manufacturing related.
  • Experience in investigating, analyzing and implementing corrective actions for customer complaints.
  • Modified Design FMEA and Process FMEA for existing product.
  • Good understanding of NCR (non-conforming report) / CR (change request) / PIR (product inquiry report) / field Action / Recall/Ship hold Processes / SAP.
  • Reviewed and resolved Material Review Board (MRB) issues by coordination with Core Team Members and detected root cause using DMAIC process and implemented appropriate corrective actions.
  • Served as Team Lead and Core Team Member in several major VIP Projects.
  • Good understanding of NPD (New product development Projects) - Next Gen Stents, serving as a reviewer for all documentation.
  • Understanding of GMP (good manufacturing practices) and ISO 14001, ISO 13485, 2003 & 21CFR 820, 210, 211 Quality System Regulations (QSR), Medical Device Directive (MDD-93/42/EEC).
  • Provided leadership role on championing departmental or cross-functional engineering initiatives.
  • Provided project direction, coaching, and mentoring for engineering and technical team personnel.
  • Proactively investigated, identified, and implemented best-in-class Quality Engineering practices.
  • Identified and implemented effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
  • Acted as an effective leader and team member in supporting quality disciplines, decisions, and practices.
  • Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
  • Facilitated training sessions for team members on quality management principles and best practices, enhancing overall competency levels within the department.

Process Engineer

Boston Scientific Corporation
10.2006 - 04.2007
  • Worked with product development and production engineers during process validation remediation (PVR) project to ensure Product Family was successfully validated (PPQ) using appropriate Test Method Validation (TMV) Protocols and Reports.
  • Supported cross-functional teams in the preparation of Reliability/Risk Assessments: reliability predictions, FMEAs, Accelerated life Testing, Design of Experiments, Control Charts, Evaluate and analysis of field performance trends and recommend corrective action when necessary.
  • Performed various Installation Qualification (IQ), wrote Protocols and reports for various IQs.
  • Assured resolution of all issues encountered during product testing. Define and integrate all testing, including qualification, validation. Used reliability testing to understand design/process issue proactively.
  • Participated in establishing and reviewing specifications/requirements for component, product and processes.
  • Defined and implemented Process Control & Monitoring systems for KPIV (key process input variables) and KPOV (key process out variables) throughout the product lines.
  • Performed Gauge R&R studies, process capability analysis and lead SPC implementation projects.
  • Designed and implemented inline and offline inspection gauges, plans and manufacturing procedures.

Education

MBA - Master of Business Administration

University of Florida
Gainesville, FL
09.2016

MS - Engineering Technology

Purdue School of Engineering & Technology
Purdue University
05.2010

BS - Electrical Engineering

Purdue School of Engineering & Technology
Purdue University
06.2006

Skills

  • Expertise in MDSAP, ISO 13485, ISO 9001, EUMDR
  • FDA Audit Management (Managed 483's and Warning Letter Responses)
  • Collaborative leadership
  • Quality Culture transformation
  • Operations Quality & Supplier Expertise
  • Technical Expertise
  • Team management
  • Policy development
  • Team building and motivation
  • Organizational development
  • Strategic planning
  • Decision-making
  • Project management

Certification

  • Master Certificate in Systems Design and Project Leadership, 2013, Cornell University
  • ASQ Certified Quality Engineer (CQE)
  • ASQ Certified Quality Auditor (CQA)
  • ASQ Certified Biomedical Auditor (CBA)
  • DRM Yellow Belt & Green Belt Certified, Medtronic

Accomplishments

  • Platinum award for Hydrotip Outer Diameter Scrap Reduction, 2008
  • Bronze award for Bart Tip Removal Project, 2008
  • Project Award for Trapezoid coil reduction project, 2008
  • Project Award for Trapezoid basket scrap reduction, 2008
  • Honorary Award for Implementation of in-line pull tester, 2008
  • Bluto Award recipient during Process Validation Remediation activity, 2007
  • Appeared in List of Outstanding Students, 2003

Training

  • GCH (Global Complaint Handling) System, SAP
  • DMAIC (Define, Measure, Analyze, Improve, Control)
  • Six Sigma Yellow and Green belt Training at Boston Scientific
  • Quality Systems Basics
  • Tolerance Stack Analysis
  • Measure System Analysis
  • SAP usage
  • Design Controls
  • Risk Management Overview
  • Gauge R & R (repeatability and reproducibility), Process Capabilities, SPC, Z1.4 &1.9, Control Charts, QMS, and Lean Manufacturing Principles
  • Quality and Productivity in Manufacturing Industry
  • AutoCAD 2006
  • Design of Experiment (DOE)
  • Process Validation/Validation Sampling Plans
  • Testing for Normality
  • Technical Report Writing

Timeline

Sr. Director Global Quality

Next Science
01.2022 - Current

Manager, Manufacturing Quality Engineering

Medtronic ENT Operations (Capital & Disposables)
01.2017 - 12.2021

Principal Quality Engineer

Medtronic
07.2016 - 12.2016

Senior Quality Engineer

Medtronic
11.2014 - 04.2016

Senior Quality Engineer

Medtronic
04.2014 - 11.2014

Senior Quality Engineer

Medtronic
12.2012 - 04.2014

Quality Engineer II

Boston Scientific Corporation
05.2012 - 11.2012

Quality Engineer II

Boston Scientific Corporation
12.2009 - 05.2012

Quality Engineer

Boston Scientific Corporation
04.2007 - 12.2009

Process Engineer

Boston Scientific Corporation
10.2006 - 04.2007

MBA - Master of Business Administration

University of Florida

MS - Engineering Technology

Purdue School of Engineering & Technology

BS - Electrical Engineering

Purdue School of Engineering & Technology

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