לוח משרות דרושים הייטק אבטחת איכות QA בנס ציונה

A ready-to-deploy, Salesforce-native eQMS with the industrys first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance.

The companys solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001.

Who were looking for
We are looking for a skilled and motivated QA Lead and CSV engineer to join our Quality and Compliance team. This hybrid role combines expertise with Healthcare Quality Assurance (QA) support and Computerized Systems Validation (CSV) , and plays a critical part in ensuring that our software and internal systems meet applicable regulatory and industry standards and within GxP environments.

QA Lead
Act as a liaison between IT and QA functions to ensure proper system implementation and ongoing compliance.
Support internal and customer-facing QA processes, including audits, CAPA, change control, and documentation.
Manage periodic reviews and revalidation processes as needed.
Maintain compliance with relevant GxP guidelines and pharmaceutical regulatory requirements.
Contribute to the development, improvement, and enforcement of SOPs and quality policies.
Responsible for quality validation product per each release

Computerized Systems Validation (CSV):
Lead and execute validation activities for GxP-regulated system in accordance with FDA 21 CFR Part 11 and EU Annex 11.
Create, review, and maintain validation documentation (VP,URS, FRS, VSR).
Plan ,Review and approve test protocols (e.g. OQ,PQ)
Collaborate with software engineering, product, and QA teams to ensure validation requirements are integrated into development and testing.

a ready-to-deploy, Salesforce-native eQMS with the industrys first AI specifically built to deliver safe, reliable decision guidance for critical quality issues. This offers faster, more proactive quality and compliance through vertical AI that empowers data-driven decision making in life sciences quality and compliance.
The companys solutions are trusted by life sciences companies, both large and small, worldwide. The solutions are fully compliant with 21 CFR part 11, EU Annex 11 and support ISO 9001, 13485, 14971, and 27001.

Who were looking for
a cloud based, innovative software company, and our product allows life science customers to manage their quality and compliance processes electronically.
As a QA automation & Testing Lead you will lead efforts to improve software validation, enhance manual testing processes, and design and implement a cutting-edge automation platform that ensures both speed and compliance. This is a strategic and hands-on role that bridges regulatory-grade quality assurance with modern test automation practices.
You will lead efforts to improve and implement a cutting-edge automation platform that ensures both speed and compliance. You will lead and improve manual testing methodologies. This is a strategic and hands-on role that bridges regulatory-grade quality assurance with modern test automation practices.

Key Responsibilities
Design and implement an automation framework that supports UI, API, and backend testing.
Evaluate and modernize manual testing procedures to improve efficiency, traceability, and scalability.
Collaborate with development, QA, and product teams to ensure testing processes are aligned with industry standards and regulatory expectations.
Create reusable and modular test libraries, automation scripts, and validation templates.
Drive continuous improvement in the test lifecycle, including risk-based testing, traceability matrix design, and automated validation reporting.
Train and mentor QA team members on both manual and automated testing best practices.