Speaker Profile


Susanne Manz

MBA, MBB, RAC, CQA

Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma.  She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.  While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance.   Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.  She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson.  Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality.  Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.  

Best Practices for Managing an FDA Inspection
Best Practices for Managing an FDA Inspection

Speaker:Susanne Manz
Time: 27th February 2017 10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Model : GRC-90094

Mon
27
Feb 2017

Audit – An Essential Tool for Continuous Improvement
Audit – An Essential Tool for Continuous Improvement

Speaker:Susanne Manz
Time: 28th June 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90117

Wed
28
Jun 2017

Quality System Structure and Development for Medical Device Companies
Quality System Structure and Development for Medical Device Companies

Speaker:Susanne Manz
Time: 24th January 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90208

Wed
24
Jan 2018

Complaint Handling and Medical Device Reporting
Complaint Handling and Medical Device Reporting

Speaker:Susanne Manz
Time: 7th June 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90140

Wed
07
Jun 2017

Requirements of Validation – IQ, OQ and PQ Protocols
Requirements of Validation – IQ, OQ and PQ Protocols

Speaker:Susanne Manz
Time: 13th December 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90196

Wed
13
Dec 2017

Root Cause Analysis and CAPA
Root Cause Analysis and CAPA

Speaker:Susanne Manz
Time: 14th November 2017 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90184

Tue
14
Nov 2017

Purchasing or a Supplier Control for Medical Devices
Purchasing or a Supplier Control for Medical Devices

Speaker:Susanne Manz
Time: 16th January 2018 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : GRC-90190

Tue
16
Jan 2018

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