Rebecca Kelderhouse
Waukesha,WI
Summary
Established quality manager with strong understanding of regulated industries with specific focus on medical devices (imaging & diagnostics). Skilled professional with proven ability to develop and improve processes. Self-motivated and able to apply critical thinking and solve problems comprehensively. Well versed in change management and appreciate the benefit of standardizing and documenting processes. Learned in Six Sigma Methodology, Risk Management, CAPA, and Design Verification/Validation. Experienced user of SAP, TrackWise, SalesForce, CA5, CPA, MiniTab.
Overview
23
23
years of professional experience
Work History
QAPS Support Specialist II
Abbott Laboratories
03.2022 - Current
- Apply quality principles, analyze quality records, prepare reports and recommend process improvements.
- Document quality issues and performance measures for management review.
- Review quality data to ensure accuracy of records processed.
- Research and identify solutions to technical problems.
- Generate reports to identify trends in customer reported concerns.
- Assess User Interface of SalesForce (Helix) for improvement opportunities and efficiency gains.
- Ensure customer concerns are addressed in a compliant and timely fashion.
- Act as Investigator as well as Approver of complaints.
- Perform Product Risk Review activities.
- Assign Investigation Activities as needed.
- Share knowledge of quality standards, company established procedures, and complaint software application.
Quality Manager/Quality Assurance Engineer, QMS
ISO Regulated Companies
01.2016 - 08.2021
- Developed Quality Strategy, Quality Management System (QMS), and Quality Control Plan
- Established quality standards, practices, and procedures to increase efficiency, reduce errors, and maximize customer satisfaction.
- Defined, Monitored, Measured, Maintained company Key Performance Indicators (KPIs)
- Lead Management Review Meetings to review effectiveness of Quality System
- Organized company to ensure compliance with ISO:9001 standards.
- Primary Contact for External Audits.
- Wrote and implemented procedures, work instructions, and training materials.
- Performed Internal Audits and Prepared site for audits.
- Guided audit action owners to apply root cause analysis and establish effective corrective action plans.
Quality, MR Design & Systems Engineering
GE Healthcare
10.2008 - 12.2015
- Reviewed Advanced Technology Software Methods Documentation.
- Managed Product Concession, Process Deviations, and Product Holds.
- Opened, executed, and closed - Nonconformities/Investigations/CAPAs/Internal Process Audits.
- Performed internal audits. Supported external audits.
- Championed the review and continual improvement of Risk Assessment and Control (RAC) process.
- Collaborated with engineering team on New Product Introduction verification and validation activities.
- Supported the development and validation of System Problem Report (SPR) ClearQuest scripts and queries.
- Educated others on the appropriate construct, documentation, routing, and retention of quality records.
Pricing and Contracting Specialist
Danaher Corporation
01.2005 - 01.2008
- Maintained SAP Customer Master as well as Price Master data
- Managed VA and DSCP government contracts held by all five dental companies in Danaher platform
- Ran price override report monthly and reviewed SOX compliance
- Performed pricing analysis reports and calculated profit margin realized on an as needed basis
- Defined procedural guidelines applicable to SAP Customer Master, Pricing, and Product Status.
Quality and Regulatory Specialist
Baxter Medical Equipment
01.2000 - 01.2005
- Utilized Change Point Analyzer (CPA) software to trend operational data
- Created queries within CA5 and utilized TrackWise to trend local CAPAs
- Initiated and updated nonconformance records within the Corrective and Preventive Action (CA5) database
- Developed quality and operational metrics charts for quarterly and annual management review meetings.
- Supported internal as well as external audits.
Education
Licenses & Certifications
Bachelor's Degree - Business, Leadership Management
Roosevelt University
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University of Iowa Psychology
Skills
- Ability to Work in Fluid Situations
- Analytical & Methodical
- Attention to Detail
- Creative Problem Solver
- Data Driven Decision-Making
- Enjoy sharing Knowledge
- Excellent Written Communication
- Flexible and Adaptable
- Highly Organized
- Passion for Learning
- Results Oriented
- Self-Motivated
- Advanced SAP Knowledge
- Business Operations
- CAPA
- cGDP & cGMP
- Change Management
- Continuous Improvement
- Database Management
- Design Process
- DMAIC
- Document Control Systems
- FDA Compliance
- FDA Regulations
- Internal & External Audit
- ISO 13485:2016
- Key Performance Indicator
- Management Reviews
- Operational Efficiency
- Plan-Do-Check-Act (PDCA)
- Process Optimization
- Project Management
- Quality Assurance
- Quality Management Systems
- Records Management Expert
- Risk Management (FMEA)
- Root Cause Analysis
- SalesForce
- Sarbanes-Oxley (SOX)
- Standard Operating Procedure
- SWOT Analysis
- TrackWise
- Training and Development
- Verification & Validation
Timeline
QAPS Support Specialist II
Abbott Laboratories
03.2022 - Current
Quality Manager/Quality Assurance Engineer, QMS
ISO Regulated Companies
01.2016 - 08.2021
Quality, MR Design & Systems Engineering
GE Healthcare
10.2008 - 12.2015
Pricing and Contracting Specialist
Danaher Corporation
01.2005 - 01.2008
Quality and Regulatory Specialist
Baxter Medical Equipment
01.2000 - 01.2005
Licenses & Certifications
Bachelor's Degree - Business, Leadership Management
Roosevelt University
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University of Iowa Psychology