Iolanda Teodor, CSSBB, BSME, BSQE

Experience

• 

  Flextronics (Pacific Device Inc.)

  Jan 1988 - Jan 1995

  Quality Engineer

  - Re-engineered packaging and improved sterilization efficiency that reduced product cost.- Reduced product scrap by replacing QC destructive testing with non-destructive methods.

• 

  Cardiotronics, Inc.

  Jan 1995 - Jan 1996

  Quality Engineer

  - Designed product quality documentation including 1st article, process control plan, quality control inspection requirements that supported ISO 9000 certification. - Developed process validation documentation that improved validation state of processes.

• 

  Cardinal Healthcare

  Jan 1996 - Jan 2001

  Supplier Quality Manager

  - Developed and implemented strategic framework for assessment, selection, review, approval, rating and certification processes of large supplier base that ensured use of high quality materials. - Enhanced R&D supplier chain that increased components reliability from 58% to 95% (FPY).

• 

  Baxter Healthcare

  Jan 2001 - Jan 2014

  Sr.Quality Manager

  - Developed and deployed corporate, division and facility quality systems including: corrective and preventive actions, nonconformance management, process validation & equipment qualification, supplier quality, etc. that ensured quality compliance to regulatory agencies expectations.- Co-authored PDA Technical Report 60: Process Validation, A Lifecycle Approach.- Performed quality assessment per ISO, cGMP, EU GMP requirements that verified compliance readiness of suppliers.- Significantly reduced top three root causes associated with quality events; exceeded human error reduction target. Show less

• 

  Quality HIT Consulting, LLC

  Jul 2014 - Jan 2021

  Principal Consultant

  Helping clients with quality control/assurance needs, including:- Quality plan/manual development, compliant with cGMP, ISO requirements/expectations- SOPs, quality documentation development & effective deployment- Quality investigations, root cause analysis, corrective actions implementation- Quality data monitoring & trending systems design, development & maintenance- Manufacturing process validation - Supplier Quality: supplier audits, qualification & maintenance, material certification- Backlog reduction/ elimination for areas including: Receiving Inspection, CAPAs, NCRs, Customer Complaints, etc. Show less

• 

  NA

  Jan 2021 - now

  Retired