now Director of Quality Assurance @ MAQUET Cardiovascular LLC
now Sr. Manager Quality Assurance and Quality Systems @ MAQUET Cardiovascular LLC
now Sr. Quality Engineering Manager @
now Process Engineering Manager @ Risdon International Inc.
now Manufacturing Engineer @ United States Surgical Corporation
Don Kraft Education
The University of Connecticut School of Business 1994-1996
Bucknell University
Don Kraft Skills
Quality Mgmt. Rep.
Quality Systems
CAPA
Root Cause Analysis
Medical Device Complaints
MDR Medical Device Reporting
Internal Audit
Design Controls
Project Management
Risk Management
Supplier Quality
Process Validation
21 CFR 820
ISO 13485
ISO 22442
21 CFR 803
21 CFR 806
ISO 14971
21 CFR Part 11
Computer System Validation
Test Method Validation
Six Sigma
FDA Compliance
21 CFR 210
21 CFR 211
Terminal Sterilization
CAPA Effectiveness
Statistical Sampling Plans
Warning Letter Remediation
Process Transfer
Stability Studies
Shelf Life Studies
Lean Manufacturing
Quality Auditing
Cross-functional Team Leadership
FMEA
Reduced Inspection
IMDRF Guidance
Development
System Development
Data Validation
Regulatory
Quality Mgmt. Rep
Regulatory Affairs
Validation
Medical Devices
Quality Assurance
Quality System
Cross Functional Team Leadership
Collagen
Don Kraft Summary
Don Kraft, based in Montville, NJ, US, is currently a Director, Quality and Compliance at Diagnostica Stago. Don Kraft brings experience from previous roles at Independent, Integra LifeSciences and MAQUET Cardiovascular LLC. Don Kraft holds a 1994 - 1996 The University of Connecticut School of Business. With a robust skill set that includes Quality Mgmt. Rep., Quality Systems, CAPA, Root Cause Analysis, Medical Device Complaints and more. Don Kraft has 3 emails and 3 mobile phone numbers on RocketReach.
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