Terri Kraycik

Greater Tampa Bay Area

+91 xxxx xxxxx

[email protected]

208 followers

Timeline
Current Company
Apr 2017 - now
Senior Client Manager, Regulatory Services (MedDevs) - Americas
BSI Group America Inc.
About me
Senior Regulatory Auditor, Medical Device - Jurisdictions: European Union, US FDA, Health Canada, Brazil ANVISA, Australia TGA, Japan MHLW/PMDA, Taiwan TFDA.
Education
- Dickinson college/st. petersburg college
  -
  Bachelor's degree technology management
- Dickinson college
  -
  Electronics engineering
- St. petersburg college
  -
  Bachelor's degree technology management
Experience
- Bsi group america inc.
  Apr 2017 - now
  Senior client manager, regulatory services (meddevs) - americas
Licenses & Certifications
- Ansi-rab, certified internal quality systems auditor
  Ansi-asq national accreditation board/anab
- Ipc j-std-001, registered instructor
  Ipc-association connecting electronics industries
- Asq, cqe, certified quality engineer
  Asq - world headquarters
- Iso 19011 – guidelines for auditing management systems
  Bsi
- Ipc-a-610, class a instructor
  Ipc-association connecting electronics industries
- Asq, cqa, certified quality auditor
  Asq - world headquarters
- Ce marking of medical devices
  Bsi
  Feb 2018
- Sor/98-282 – canadian medical device conformity assessment system
  Smith & nephew
- Rabqsa certified iso 9001:2008 lead auditor
  Asq - world headquarters
- European council directive 93/42 / eec rev. a – medical devices directive
  Smith & nephew
- Medqs-ct, certification in medical quality systems (iso 13485, iso 14971, & 21cfr820)
  St. petersburg college
- Six sigma / design for six sigma certified
  Honeywell aerospace
- Iso 13485:2016 lead auditor
  Bsi
- Mdsap (medical device single audit program)
  Bsi
  Apr 2018
- Medical devices - mdr (eu) 2017/745
  Bsi
  Apr 2021