KATHARINA BONNEAU
Leesburg,VA
Summary
Medical device quality professional with senior-level coordination experience in MRB activity, supplier returns, material dispositions, and document control. Known for resolving documentation and inventory issues across Quality, Engineering, Supply Chain, and suppliers while supporting audit readiness and controlled procedures.
Overview
17
17
years of professional experience
Work History
Senior Quality Coordinator
VB Spine (formerly Stryker / K2M)
Leesburg, VA
12.2021 - Current
- Quality Coordinator | December 2018–December 2021
- Reduced the open supplier RMA backlog by more than 50%, from 118 to 57 lines, within two weeks in July 2026 through tracker reconciliation and supplier and Procurement follow-up.
- Processed 345 supplier RMAs in 2025, maintaining tracking records, preparing required paperwork, and coordinating approved returns with Shipping.
- Coordinate execution of approved dispositions with Quality, Engineering, Operations, Supply Chain, and suppliers, including JDE transactions and physical material movement.
- Coordinate weekly Material Review Board (MRB) meetings covering approximately 15 Quarantine Tickets across Sustaining, New Product Development, and Specials; assumed primary coordination in 2025 after supporting MRB since 2020.
- Prepare defect presentations and supporting records, document disposition decisions, revise Quarantine Tickets, and route records through Adobe Sign for approval.
- Work with suppliers to resolve rejected-part issues, missing certificates, and inspection discrepancies; provide photographs, videos, and inspection details and track outstanding actions.
- Own and maintain departmental controlled procedures in MasterControl; revise procedures and transition documents to VB Spine templates, coordinate approval routing, and identify outdated references.
- Oversee departmental DHR scanning, including record collection, scanning preparation, lot and part tracking, quality spot checks, and preparation for controlled storage.
- VB Spine (formerly Stryker / K2M) | Experience continued
- Review approximately 20 scanned records weekly for accuracy, completeness, and GDP; coordinate correction of duplicate files, incorrect document identifiers, and missing records.
- Perform approximately 20 final inspection documentation checks weekly to verify required paperwork is present and complete; identify discrepancies and coordinate corrections.
- Perform dimensional inspections using measuring equipment, support incoming inspection as needed, and carry out final inspection activities weekly, including gauge-based reinspection.
- Create DHR scanning instructions with photographs and video and serve as a resource for employees on scanning procedures and documentation questions.
- Resolve JDE inventory discrepancies involving lots in holding locations, negative balances, and scrap records; prepare Disposal Authorization Requests for Finance.
- Assist with gage calibration coordination, approved supplier list changes, and updates to inspection reports and plans.
- Assisted in preparing documentation for BSI audits and ensured quarantine areas met compliance standards.
- Regulatory & Quality Coordinator | April 2018–December 2018
- Created and maintained 510(k) regulatory records in MasterControl, updated supplier quality documentation including ISO 13485 certificates, and prepared engineering documents for upload to Windchill.
Administrative / Payroll Assistant
Z&M Sheet Metal
Chantilly, VA
01.2014 - 11.2017
- Recorded and verified payroll data for sheet metal crews and office staff to ensure accurate payroll processing.
- Reviewed timecards, attendance, and overtime for payroll accuracy, ensuring compliance with company policies and reducing discrepancies.
- Processed accounts payable in QuickBooks, recorded bank deposits, maintained payroll records, and addressed employee payroll and benefits inquiries to ensure timely and accurate compensation.
- Maintained employee files, wage data, and benefit deductions
Surgical Coordinator / Office Manager
Eye Physicians and Surgeons, Inc.
Fairfax, VA
03.2010 - 01.2014
- Coordinated surgical schedules for ophthalmology patients at Eye Physicians and Surgeons.
- Coordinated surgical scheduling and documentation, facilitated communication between patients and medical staff, and resolved outstanding balances and claims for patients and insurers.
- Prepared preoperative paperwork, referrals, and patient charts for procedure days.
- Verified insurance authorizations and surgery coverage requirements with payers.
Education
Medical/Clinical Assistant Certificate -
Sanz School
Falls Church, VA01-2011
Management Assistant for Office Management - Apprenticeship / Dual Track
Vocational School Center for Business, Healthcare, and Technology of the Zwickau District
Zwickau, Germany01-2008
Skills
- MRB Coordination
- Nonconformance Records
- Material Dispositions
- Supplier Returns
- Device History Records (DHR)
- Audit readiness
- Document Control
- Good Documentation Practices (GDP)
- Procedure Revisions
- Dimensional Inspection
- Systems: MasterControl eQMS
- JD Edwards (JDE)
- Adobe Sign
- Microsoft Excel
AWARDS AND LANGUAGES
German: Native / Bilingual
Awards
Stryker Spine Peer Recognition Award | 2023, Stryker GQO Quality MVP | July 2023, Stryker Quality MVP | April 2021
Timeline
Senior Quality Coordinator
VB Spine (formerly Stryker / K2M)
12.2021 - Current
Administrative / Payroll Assistant
Z&M Sheet Metal
01.2014 - 11.2017
Surgical Coordinator / Office Manager
Eye Physicians and Surgeons, Inc.
03.2010 - 01.2014
Medical/Clinical Assistant Certificate -
Sanz School
Management Assistant for Office Management - Apprenticeship / Dual Track
Vocational School Center for Business, Healthcare, and Technology of the Zwickau District