Syeda A Batool

Quality Engineer with 5+ years of experience in medical device and manufacturing environments, specializing in complaint investigation, root cause analysis, and regulatory compliance. Strong expertise supporting orthopedic products (knee, hip, and extremities) and quality systems aligned with FDA 21 CFR 820, ISO 13485, and IATF 16949. Proven ability to resolve complex quality issues, support product launches, and drive continuous improvement.

Quality Engineer - ENNOVI - Northvale, NJ

(2025-08)

• Lead APQP and PPAP submissions, ensuring compliance with IATF 16949 and customer-specific requirements
• Serve as primary customer quality contact, directly handling complaints, clarifying expectations, and ensuring timely issue resolution
• Own end-to-end PPAP readiness, coordinating submissions and resolving feedback to achieve approvals
• Develop Control Plans, Process Flow Diagrams, and PFMEA to improve manufacturing processes
• Perform dimensional inspections using GD&T and engineering drawings
• Prepare and review First Article Inspection (FAI) and dimensional reports to ensure product compliance
• Analyze dimensional data and collaborate with production teams to resolve non-conformances
• Conduct shop floor audits to verify processes meet control plans and quality requirements
• Monitor production to ensure adherence to specifications and stable process performance
• Perform process capability studies (Cp, Cpk) and support continuous improvement initiatives

Quality Engineer - Johnson & Johnson - West Chester, PA

(2022-01 - 2024-12)

• Led CAPA activities including initiation, investigation, root cause analysis, and effectiveness verification for product and process issues
• Conducted in-depth failure investigations for orthopedic devices, identifying root causes and implementing sustainable corrective actions
• Ensured CAPA documentation met FDA 21 CFR 820 and ISO 13485 requirements and maintained audit readiness
• Analyzed complaint trends and quality data to drive proactive corrective and preventive actions
• Supported risk management activities (ISO 14971), including DFMEA and PFMEA across product lifecycle
• Managed Design History Files (DHF) and ensured accuracy, traceability, and compliance of quality documentation
• Reviewed and approved validation protocols (IQ/OQ/PQ), reports, and engineering changes (ECOs)
• Performed documentation reviews of DMRs and technical files to ensure completeness and regulatory compliance
• Collaborated with cross-functional teams to improve product quality, reliability, and patient safety
• Supported internal and external audits, ensuring compliance with regulatory and quality standards

Quality Assurance Specialist - Abbott - Chicago, IL

(2020-02 - 2021-11)

• Reviewed and investigated customer complaints, ensuring accurate documentation and timely resolution of product issues
• Communicated directly with customers to gather detailed information, clarify concerns, and support effective issue resolution
• Conducted detailed complaint evaluations and root cause analysis to identify product and process issues
• Prepared comprehensive complaint investigation reports in compliance with FDA and quality system requirements
• Reviewed DHRs and batch records to ensure product quality, accuracy, and compliance
• Performed product testing and evaluation to support complaint investigations
• Identified complaint trends and escalated recurring or critical issues to cross-functional teams
• Ensured all complaint handling activities followed GMP, GDP, and regulatory standards
• Collaborated with internal teams to improve product quality and enhance customer satisfaction

Bachelor of Science - Industrial Engineering - New Jersey Institute of Technology (NJIT)

Associate Degree - Engineering Science - Essex County College