Misbah Naz
Chatsworth,CA
Summary
Results-driven Product Quality Analyst with over 15 years of expertise in regulatory affairs and compliance, specializing in Class II and III medical devices. Proven track record in leading submission strategies that ensure compliance with global standards, including EU MDR and ISO 13485 and 14971. Recognized for building and mentoring detail-oriented teams through tailored training programs and constructive feedback, fostering a culture of excellence in product quality assurance within the healthcare sector.
Overview
20
20
years of professional experience
Work History
Senior Quality Specialist
Advanced Bionics
02.2026 - Current
- Crafted and launched compliance strategies securing regulatory conformity throughout multiple departments.
- Facilitated risk assessments to detect compliance vulnerabilities and recommend appropriate mitigation strategies.
- Ensure compliance with regulatory standards including FDA regulations ISO standards (ISO 9001/13485) and GMP guidelines.
- Perform internal, external, and supplier audits; train teams for inspections and correct audit findings with effective corrective actions.
- Administer and sustain quality management system (qms) featuring sop creation, document regulation and continuous process improvements.
- Identify compliance risks and implement preventive strategies to improve product and process quality.
- Develop and deliver training programs on compliance policies, procedures, and regulatory updates.
- Oversee supplier qualification, audits, and performance monitoring to ensure adherence to quality standards.
Product Quality Analysts
Abbott Laboratories
09.2024 - 04.2025
- Led complaint investigations in compliance with FDA and regulatory guidelines, independently collaborating with field staff and customers to identify root causes and recommend actions.
- Authored and submitted comprehensive regulatory reports to authorities, ensuring data accuracy, legal compliance, and strict confidentiality across all communications.
- Performed CAPA (Corrective and Preventive Action) investigations related to product complaints, supporting quality assurance and continuous improvement initiatives.
- Provided critical support during FDA and TUV audits, contributing documentation, systems knowledge, and process clarity to ensure successful inspection outcomes.
- Managed adverse event reporting processes, including case analysis, follow-ups, regulatory notifications, and agency communications for timely compliance.
- Supported enhancements to global complaint databases, including data input, testing, and analysis to drive system optimization and usability.
- Coordinated clinical study operations for cardiovascular implantable devices, overseeing study design documents, data management, and cross-functional collaboration with investigators and labs.
- Ensured adherence to global pharmacovigilance protocols, including SOP implementation, safety report drafting (e.g., PSURs, signal detection), and regulatory document archiving.
Quality Assurance Specialist
Sanisure
05.2024 - 09.2024
- 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.
- Experienced with risk management per ISO 14971 system risk analysis, user analysis and DFMEA/FMEA risk management tools.
- Conduct detailed audits of internal processes and supplier operations, identifying nonconformities, assessing risk levels, and developing 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 evaluations 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.
- 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
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.
- Initiated and assessed complaints in accordance with organizational policies and regulatory requirements.
- Compiled and submitted detailed reports of findings to competent authorities, ensuring accuracy, confidentiality, and compliance with legal standards.
- Liaised with regulatory bodies and internal stakeholders to facilitate effective resolution and follow-up of reported issues.
- Cultivated communication and collaboration with strategic partners such as Becton Dickinson, Uno Medical, and Ascencia, addressing inquiries and managing information requests to optimize complaint-handling processes.
- Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation.
- Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data.
Product Reporting Specialist II
Medtronic
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 creation, 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.
Project Coordinator
Medtronic
11.2006 - 07.2016
- Supervised the importation of complaint records into the Easy Trak 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.
Customer Service Representative
Medtronic
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.
Education
Master of Business Administration (MBA) -
University of Phoenix
Phoenix, AZ12.2014
Bachelor of Science - Real Estate & Finance
California State University Northridge
Northridge, CA01.2006
Skills
- Project Management, Medical Device Reporting (MDR), Strategic Planning,
- DMAIC methodology application
- Software Proficiency: SmartSolve, Agile, Microsoft Office Suite, Windows, Qt-9, SyteLine
- Database and Reporting Tools: SAP, Flat File Interface, Easytrak, Crystal Report Software
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.
- 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.
- 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.
- Team Development | Leadership Excellence
- Provided hands-on guidance to team members during the detailed review of international complaints while prioritizing consistency and thoroughness, cultivating a culture of excellence, and fostering professional development within the team.
Timeline
Senior Quality Specialist
Advanced Bionics
02.2026 - Current
Product Quality Analysts
Abbott Laboratories
09.2024 - 04.2025
Quality Assurance Specialist
Sanisure
05.2024 - 09.2024
Associate MDR Vigilance Specialist
Medtronic
07.2016 - 05.2024
Product Reporting Specialist II
Medtronic
11.2006 - 07.2016
Project Coordinator
Medtronic
11.2006 - 07.2016
Customer Service Representative
Medtronic
04.2006 - 11.2006
Bachelor of Science - Real Estate & Finance
California State University Northridge
Master of Business Administration (MBA) -
University of Phoenix