Software Implementation Quality Engineer

Phoenix, Arizona

Local Only

Full Time

$85k - $105k

Our client that is based in Phoenix/Scottsdale border is looking to hire QA Implementation Engineer. They are a leader in provider of Health and Life Science automation solutions for their various Healthcare Clients.

They are a Software platform for organizations in the Health and Life Sciences space.

They are looking to bring on a QA Engineer that will focus on Quality Assurance of their software system during and at completion of a customer deployment. They need someone that has exposure to Health or Life Science regulatory QA.

They are looking for someone that has experience using or implementing QMS such as Veeva, Sparta, Mastercontrol, Q-Pulse and/or CGT Manufacturing Systems such as PasX, POMS, Apprentice, GE MES or ERP systems when deployed in the cGMP environment. Also, some experience doing scripting using either JavaScript, Python or PowerShell. Lastly some experience in FDA, ISO 9000, AABB, FACT ISBT or similar standards/regulations.

This will be a Full-Time position, onsite to start out of their Phoenix/Scottsdale office and looking to hire right away. If this sounds like something you could be interested in, apply today! Required Skills & Experience
  • 4+ years of QA experience
  • Experience working in environments whose software systems must comply with FDA Computerized Systems validations, 21CFR Part 11, GAMP 5 (Level 4) validation and similar regulatory requirements.
  • Experience in testing clinical or commercial cGMP application (web and desktop-based applications) solutions in the customers test environments.
  • Experience planning, creating, and documenting test cases (manual).
  • Microsoft SQL Server (T-SQL)
  • Experience using or implementing QMS such as Veeva, Sparta, Mastercontrol, Q-Pulse
  • and/or CGT Manufacturing Systems such as PasX, POMS, Apprentice, GE MES or ERP systems when deployed in the cGMP environment (SAP, NetSuite).
  • Experience with FDA (GxP, 510(k)), ISO 9000 (13485), AABB, FACT, ISBT and similar standards/regulations.
  • Experience with at least one scripting language, e.g. JavaScript, Powershell.
Desired Skills & Experience
  • Experience with common QA systems such as error management, CAPAs and RCA, Change Control, Audit, Supply and Consumables Management, Equipment Management, etc.
What You Will Be Doing Tech Breakdown
  • Manual focused with some Little Scripting Automation
Daily Responsibilities
  • 100% Hands On
The Offer You will receive the following benefits:
  • Medical Insurance
  • Dental Benefits
  • Vision Benefits
  • 401k Match
  • PTO
  • Life/Disability Plan
  • HSA

Applicants must be currently authorized to work in the US on a full-time basis now and in the future.

Posted by: Grant Nebel