Summary
Overview
Work History
Education
Skills
Certification
Timeline
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Kara Bell

St. Paul,MN

Summary

Manufacturing Supplier Quality Engineer Professional with over 20 years of medical device experience. Proven performance in process and equipment validation, production planning, project management, product line management, supply chain management and complaint investigation. Working knowledge of inventory control, NCM/CAPA investigations, raw material procurement, FDA and ISO requirements, quality documentation and instrumentation. Bring inventive, successful solutions to both internal and external customers.

Quality assurance professional with strong foundation in supplier management and quality control. Known for improving supply chain reliability and maintaining high standards of product quality. Focused on team collaboration and adaptability to changing needs, ensuring operational excellence and consistent results.

Overview

32
32
years of professional experience
1
1
Certification

Work History

Supplier Quality Engineer

ZOLL Medical
12.2015 - 01.2025
  • -Qualify and Monitor component suppliers’ QMS and manufacturing processes
  • -Validate manufacturing processes and equipment via IQ, OQ PQ and PPAP activities including Gage R&R, Cpk, GD&T and DMAIC analyses
  • -OEM manufacturing support, both domestic and international
  • -Monitor and investigate supplier non-conformances via CAPA, SCAR and NCM processes
  • -Development/NPI work with multifunctional team on plastic injection molding, silicone molding and PCBA qualification
  • -Perform pFMEA and dFMEA risk analyses
  • -Maintain FDA and ISO compliance
  • -Participate in certification, compliance and internal audits

Manufacturing Quality Engineer

Medtronic
09.2014 - 12.2015
  • -Performed validation activities for remediation effort
  • -Validated manufacturing processes, equipment and test methods via IQ, OQ, PQ activities
  • -Qualified sterile packaging configurations, test methods, parts cleaning and silicone molding
  • -Performed FMEA risk analysis
  • -Maintained FDA and ISO compliance
  • -Worked with multifunctional team to implement validation remediation plan

Supervisor/Manager Serum Proteins Manufacturing

DiaSorin Inc.
05.1996 - 09.2013
  • -Led process improvement projects, production planning activities and inventory control
  • -Raw material sourcing, evaluation and vendor qualification activities
  • -Developed, validated and implemented new products
  • -Validated, planned and executed critical to quality production data trending project
  • -Implemented and managed $25MM OEM contract product line
  • -Compiled and analyzed KPI metric data
  • -Performed pFMEA and maintained documentation
  • -Validated manufacturing processes and equipment via IQ, OQ, PQ and PPAP activities
  • -Consulted for technical and customer service departments
  • -Managed complaint and CAPA investigation activities
  • -Ensured compliance to EHS requirements
  • -Executed packaging and labeling development projects

Protein Chemist

Sanofi Diagnostics (Now Beckman Coulter)
06.1993 - 05.1996
  • -Purified, conjugated and characterized sera for use in clinical diagnostics
  • -Managed and characterized raw materials
  • -Performed chromatography – affinity, ion exchange and size exclusion
  • -Performed antibody conjugation – FITC and HRP
  • -Contributed in obtaining ISO9000 certification for Serum Proteins product line
  • -Contributed in standardizing Serum Proteins products to new RPPHS world standard

Education

BS - Genetics and Cell Biology

University of Minnesota
Minneapolis, MN

Certificate - ISO 13485:2016 Lead Auditor

British Standards Institution
12.2018

Masters Certificate - Project Management (PMP)

Villanova University
10.2014

Skills

  • Microsoft Excel, Power Point, Word, Project, Minitab, SAP (ERP), Smart Solve and Agile

Certification

Certified Project Management Professional (PMP)

Timeline

Supplier Quality Engineer

ZOLL Medical
12.2015 - 01.2025

Manufacturing Quality Engineer

Medtronic
09.2014 - 12.2015

Supervisor/Manager Serum Proteins Manufacturing

DiaSorin Inc.
05.1996 - 09.2013

Protein Chemist

Sanofi Diagnostics (Now Beckman Coulter)
06.1993 - 05.1996

Certificate - ISO 13485:2016 Lead Auditor

British Standards Institution

Masters Certificate - Project Management (PMP)

Villanova University

BS - Genetics and Cell Biology

University of Minnesota

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Kara Bell