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Coco Panda

Quality Systems Specialist
PROFESSIONAL SUMMARY

Quality Systems Specialist with 6+ years of experience supporting FDA-regulated and ISO-certified manufacturing environments. Strong background in CAPA, document control, internal audits, nonconformance management, and training compliance. Known for improving audit readiness, reducing overdue quality actions, and strengthening cross-functional process adherence.

SKILLS
CAPA Management
Document Control
Internal Auditing
Nonconformance Handling
FDA 21 CFR 820
ISO 9001 / ISO 13485
CERTIFICATIONS
Certified Quality Auditor (CQA) - ASQ
May 2023

Credential earned.

Certified Quality Improvement Associate (CQIA) - ASQ
Oct 2021

Credential earned.

PROFESSIONAL EXPERIENCE
Apr 2021
Present
MedCore Devices
Medical DevicesFDA Regulated
Quality Systems Specialist
CAPACompliance
Milwaukee, WI
  • Managed CAPA workflow for 45+ investigations annually, reducing overdue actions by 38% through tighter owner accountability, weekly review cadence, and standardized closure documentation.
  • Maintained document control for 600+ SOPs, forms, and work instructions, improving revision accuracy and cutting approval cycle time by 27%.
  • Coordinated internal audit schedules across manufacturing, warehouse, and quality functions, helping the site complete 100% of planned audits on time for two consecutive years.
  • Supported external FDA and ISO 13485 audits by preparing records, tracking observations, and driving corrective actions, contributing to zero major findings in 2023.
  • Partnered with training, operations, and engineering teams to improve quality training compliance from 89% to 98% within six months.
Jun 2018
Mar 2021
NorthPoint Packaging
Packaging ManufacturingISO 9001
Quality Assurance Coordinator
Document ControlAudits
Waukegan, IL
  • Reviewed nonconformance records, deviation reports, and customer complaints, helping reduce repeat quality events by 22% through stronger root cause tracking.
  • Administered controlled documentation and change records for production and warehouse processes, improving document retrieval speed during audits by 35%.
  • Assisted with supplier quality issue investigations and corrective action follow-up, improving on-time supplier response rates from 71% to 93%.
  • Monitored training matrices and quality records for 150+ employees, increasing completion accuracy and reducing audit-related documentation gaps across three departments.
EDUCATION
Aug 2014
May 2018
Illinois Institute of Technology
ManufacturingQuality Systems
Bachelor of Science in Industrial Technology and Management
Chicago, IL

Focused on quality systems, process improvement, and manufacturing operations.

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