Renata Kowalski

Profile

Quality Assurance Manager with 11 years of experience in medical device and consumer electronics manufacturing, specializing in ISO 13485 compliance and supplier quality programs. Reduced field defect rates by 38% over three years at Meridian Medtech by rebuilding incoming inspection protocols and introducing risk-based audit scheduling. Certified Quality Engineer (CQE) and Six Sigma Black Belt with a track record of building QA teams from the ground up and sustaining zero FDA warning letters across four product lines.

Work Experience

Quality Assurance ManagerMar 2019 - Present

Meridian Medtech Solutions, Columbus, OH

Rebuilt incoming inspection program for 140+ component SKUs, cutting incoming rejection escapes by 52% and reducing line stoppages attributed to material defects from 18 to 4 per quarter within 18 months.
Led cross-functional team of 9 to achieve ISO 13485:2016 re-certification with zero major nonconformances, completing the audit cycle 3 weeks ahead of schedule and under budget by $14,000.
Designed and deployed a supplier corrective action (SCAR) tracking system in Salesforce, reducing average SCAR close-out time from 47 days to 19 days and improving on-time supplier response rate from 61% to 94%.

Senior Quality EngineerJun 2015 - Feb 2019

Vantage Consumer Electronics, Cincinnati, OH

Managed FMEA and control plan development for a new wireless charging product line, identifying 23 high-severity failure modes before pilot build and preventing an estimated $2.1M in potential warranty costs.
Championed a statistical process control (SPC) rollout across 6 production lines, increasing Cpk averages from 1.12 to 1.67 and reducing customer-reported defects by 29% in the first year post-launch.
Mentored and assessed 5 junior quality engineers, all of whom passed CQE certification within 14 months, strengthening departmental bench depth ahead of a 40% production volume increase.

Quality Assurance EngineerAug 2012 - May 2015

Hartwell Precision Components, Dayton, OH

Executed first-article inspection (FAI) and dimensional reporting for aerospace-grade machined parts, maintaining a 99.2% on-time delivery rate to Tier 1 customers across a 3-year tenure.
Developed internal audit schedule and checklist library aligned to AS9100 Rev C, enabling the facility to pass its first third-party surveillance audit with zero findings.
Reduced inspection cycle time by 34% by transitioning manual measurement logs to a CMM-integrated SPC software platform, freeing 11 labor-hours per week for value-added quality activities.

Profile

Work Experience

Education

Skills

Links