Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Timeline
Generic

Misbah Naz

Chatsworth,CA

Summary

Seasoned Quality Assurance Specialist with 18 years of experience in medical device compliance and product development. A proven track record in leading submission strategies for Class III medical devices, ensuring adherence to global standards such as EU MDR and ISO 13485. Expert in streamlining regulatory processes, managing international requirements, and developing cybersecurity procedures. Adept at guiding teams and fostering a culture of regulatory excellence.

Overview

19
19
years of professional experience

Work History

Product Quality Analyst

Abbott
Sylmar, CA
09.2024 - Current
  • Assisting the department manager in ensuring all global medical device reports are filed within regulatory timeframes.
  • Represents Product Surveillance at cross-functional meetings as requested or in the absence of the department manager.
  • Provides training on complaint reporting to other groups
  • Supports Product Surveillance Data Analyst by performing trending
  • Supports complaint database upgrades, changes, conversions through design input, testing, maintenance functions
  • Ensures complaint information on intranet sites is maintained
  • Orders department supplies in accordance with budget
  • Support inspections by regulatory agencies (e.g. FDA, TUV) as requested
  • Assists in training new employees and maintaining training documents
  • Is vigilant of product complaint trends
  • Ensures department procedures and work instructions are maintained
  • Supporting and instruct other department members as needed on product complaint investigations and devices
  • Collaborate independently with other team members and departments needing product complaint information
  • Conduct investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
  • Be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
  • Use procedures, judgment, and experience to determine appropriate testing of returned products with minimal guidance.
  • Perform CAPA investigations as they relate to complaint reporting
  • Support the department manager in their absence.
  • Provide support to Legal Dept on product complaints
  • Support all company initiatives as identified by management, and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

Quality Assurance Tester

SANISURE
Camarillo, CA
05.2024 - Current
  • Lead quality assurance efforts by collaborating with cross-functional teams to identify quality gaps, implement corrective actions, and ensure compliance with regulatory standards and quality management systems, enhancing product reliability and consistency
  • Oversee and refine the quality control processes, including document control, internal audits, and calibration of equipment, ensuring adherence to stringent quality standards and continuous improvement in manufacturing and testing procedures
  • Conduct detailed audits of internal processes and supplier operations, identifying nonconformities, assessing risk levels, and driving quality improvements through effective communication and action plans to maintain high industry compliance standards
  • Develop and manage comprehensive regulatory submissions, ensuring compliance with national and international guidelines, and maintain up-to-date documentation to support product approvals and market readiness
  • Direct and execute thorough validations of equipment, processes, and software, ensuring all systems meet required performance criteria, and maintain a proactive approach in managing calibration and maintenance schedules to prevent equipment downtime
  • Supervise the quality management system's streamlined processing of reports on international experience, ensuring strict compliance with regulatory requirements
  • Monitor environmental conditions in cleanrooms, conduct bioburden assessments, and lead investigations into microbial failures, providing data-driven solutions to uphold product safety and meet stringent cleanliness standards

Associate MDR Vigilance Specialist

Medtronic, Inc.
07.2016 - 05.2024
  • Monitored the development of regulatory directives pertaining to medical device reporting (MDR) and assessed the eligibility of incoming complaints concerning diabetes products for MDR
  • Conducted comprehensive record-keeping in accordance with regulatory standards while methodically documenting product feedback in the Global Complaint Handling (GCH) system
  • Demonstrated expertise in complaint management protocols, effectively assessing and drafting detailed and accurate complaints while navigating regulatory frameworks such as those of the Asia Pacific, FDA, and Canada
  • Cultivated communication and collaboration with strategic partners such as Becton Dickinson, Uno Medical, and Ascenia, addressing inquiries and managing information requests to optimize complaint-handling processes

Product Reporting Specialist II

Medtronic, Inc.
Northridge, CA
11.2006 - 07.2016
  • Managed regulatory inquiries for the FDA and foreign competent authorities, confirming uncompromising allegiance to regulatory requirements and timely submission of regulatory forms, such as the MDR 3500A Form
  • Oversaw complaint management processes, including record importation, event evaluation, and customer correspondence, while actively participating in investigations, including Med Watch reports and Uno Medical inquiries
  • Designed and implemented streamlined procedures focused on maximizing efficiency and effectiveness, which included refining the complaint closure process and establishing protocols for importing complaint records
  • Proposed valuable support during internal audits by providing constructive feedback on departmental documents and procedures to confirm alignment with internal standards and regulations

Customer Service Representative

National Notary Association
04.2006 - 11.2006
  • Efficiently managing incoming calls, I provided clear instructions on notary license procedures, assisted with renewals, processed orders for notary packages, supplies, and training seminars, and conducted thorough database searches for client data and records
  • Resolved client inquiries and concerns with efficiency, facilitated smooth license application processes, and strategically promoted membership packages, resulting in a notable increase in notary memberships and revenue generation

Project Coordinator I

Medtronic, Inc.
Northridge, CA
06.2006 - 11.2006
  • Supervised the importation of complaint records into the Easytrak database using SAP and the Flat File Interface, ensuring that the data remained accurate and intact at all times
  • Leveraged Crystal Report software to extract and analyze international complaint reports, yielding actionable insights into product performance and offering detailed recommendations for enhancement
  • Led and supported the team with strong leadership, guiding members through the detailed review of international complaints, fostering collaboration, and ensuring unwavering adherence to regulatory standards
  • Executed comprehensive and meticulous reviews of records, making judicious decisions on medical products in strict accordance with FDA guidelines, thus upholding stringent quality assurance standards

Education

Master of Business Administration (MBA) -

University of Phoenix
Phoenix, AZ
01.2014

Bachelor of Science - Real Estate & Finance

California State University Northridge
Northridge, CA
01.2006

Skills

  • Project Management
  • Medical Device Reporting (MDR)
  • Strategic Planning
  • Medical Training & Assisting
  • DMAIC
  • FDA Regulations
  • Global Complaint Handling
  • Pathway Evaluation
  • Quality System Regulations
  • SOP Development
  • Product Claim Support
  • Regulatory Compliance
  • Product & Development Analysis
  • Root Cause & Compliance Analysis
  • Data Privacy
  • Database Administration
  • Continuous Improvement
  • Risk Management
  • Stakeholder Management
  • Technical Support
  • Process Optimization
  • Team Collaboration & Leadership
  • Organization Skills
  • Quality Assurance

Accomplishments

  • Complaint Handling | Enhanced Performance, Streamlined complaint handling processes were developed and implemented, achieving over 99.1% of the optimized goal for Canada reporting complaint timeliness. This initiative significantly improved performance and heightened customer satisfaction.
  • Compliance Leadership | Strategic Management, Spearheaded the thorough management and processing of foreign experience reports across diverse international markets, ensuring careful compliance with stringent regulatory standards and enhancing our reputation as a trusted and compliant manufacturer globally.
  • Procedural Overhaul | Operational Efficiency, Initiated a comprehensive overhaul of complaint closure procedures, resulting in increased productivity and efficiency, fostering a culture of continuous improvement and organizational excellence, ultimately enhancing operational effectiveness and client satisfaction.
  • Team Development | Leadership Excellence, Provided hands-on guidance to team members during the review of international complaints while prioritizing consistency and thoroughness, cultivating a culture of excellence, and fostering professional development within the team.

Timeline

Product Quality Analyst

Abbott
09.2024 - Current

Quality Assurance Tester

SANISURE
05.2024 - Current

Associate MDR Vigilance Specialist

Medtronic, Inc.
07.2016 - 05.2024

Product Reporting Specialist II

Medtronic, Inc.
11.2006 - 07.2016

Project Coordinator I

Medtronic, Inc.
06.2006 - 11.2006

Customer Service Representative

National Notary Association
04.2006 - 11.2006

Master of Business Administration (MBA) -

University of Phoenix

Bachelor of Science - Real Estate & Finance

California State University Northridge

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Misbah Naz