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Sandra K Koralewski

from Rogers, MN
Age ~61
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Also known as:
Sandy K Koralewski
Connected to:
Aaron G Koralewski, 42Julie A Koralewski, 61Kelly M Koralewski, 52Mariusz A Koralewski, 44Ryan E Koralik, 41Alice F Koran, 63Claire C Koran, 51Stephanie L Koran, 40Susan L Koran, 68Wesley M Koran, 85

Sandra Koralewski Phones & Addresses

  • Rogers, MN
  • New Hope, MN
  • 209 Franklin Ave, Delano, MN 55328 (763) 972-2788

Work

Company: Mainstay medical Oct 2018 Position: Quality manager

Education

Degree: Bachelors, Bachelor of Arts, Bachelor of Science School / High School: University of Northwestern - St. Paul 2011 to 2013 Specialities: Marketing, Business Management, Business, Management

Skills

Fda • Iso 13485 • Medical Devices • Capa • Quality System • Quality Assurance • 21 Cfr • Gmp • Regulatory Affairs • V&V • Validation • Design Control • Quality Systems • Six Sigma • Product Development • Cross Functional Team Leadership • 21 Cfr Part 11 • Ce Marking • Process Improvement • Iso 14971 • Business Process Improvement • Operations Management • Management • Public Speaking • Communication • Project Management • Data Analysis • Web Analytics • Fda Gmp

Ranks

Certificate: Asq-Cba; Asq-Cqa; Rab/Qsa Auditor

Industries

Medical Devices

Resumes

Resumes

Sandra Koralewski Photo 1

Quality Manager

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Location:
2750 Sand Hill Rd, Menlo Park, CA 94025
Industry:
Medical Devices
Work:
Mainstay Medical
Quality Manager
Carefusion Jun 2015 - 2017
Director of Quality Assurance
Carefusion May 2002 - Jun 2015
Qs and Ra Manager
Vital Images, Inc. 2001 - 2002
Qa and Ra Specialist
Aequitron Medical/Mallincrodt/Tyco 1987 - 2001
Quality Assurance and Document Control
Education:
University of Northwestern - St. Paul 2011 - 2013
Bachelors, Bachelor of Arts, Bachelor of Science, Marketing, Business Management, Business, Management
Skills:
Fda
Iso 13485
Medical Devices
Capa
Quality System
Quality Assurance
21 Cfr
Gmp
Regulatory Affairs
V&V
Validation
Design Control
Quality Systems
Six Sigma
Product Development
Cross Functional Team Leadership
21 Cfr Part 11
Ce Marking
Process Improvement
Iso 14971
Business Process Improvement
Operations Management
Management
Public Speaking
Communication
Project Management
Data Analysis
Web Analytics
Fda Gmp
Certifications:
Asq-Cba; Asq-Cqa; Rab/Qsa Auditor
Asq-Cba; Asq-Cqa; Asq-Cqm/Oe
Six Sigma Foundations
Communicating With Confidence
Project Management Foundations: Risk
Learning Minitab
Iso 13485:2016 Lead Auditor, Md, Au
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Sandra K Koralewski from Rogers, MN, age ~61 Get Report