QA Validation

Summary

Compliance, Validation Activities, testing, SDLC Quality, SAMD, DCT, ISO 13485, ISO 14971, IEC62304. 21CFR Part 11.
Hi! I have more than 9 years of Software testing experience, ISTQB foundation level certified, over 4 years in the SAMD environment, I work well in a highly regulated environment, I can translate regulatory requirements into SOPs and day to day actives, I perform CSV/CSA transitions.
I'm good with audits explaining how processes work and what is done to be compliant.
I manage a team of 15 people which I interviewed, hired and trained all by myself. I have reported directly to VP and Chief levels.

Expectations

I'm looking for new challenges, I can deal with start up type of processes and we'll established companies. I can drive the change for the next wave of compliance in software testing and validation.

Employment Preferences

Expected Base Salary

**,000 EUR

Expected Hourly Rate

** EUR/hr

Academic Degree

Experience

Skills

• SAMD
• ISO13485
• ISO 14971