Computerized System Validation Projects Manager

Mediqa at the glance

Mediqa Provides an unbiased perspective on quality and engineering since 2021, we support healthcare companies in rolling out products and accelerating the approval of safe and effective products.  

Apart from a systematic services with quality engineering at the helm, Mediqa helps its clients derive business and operational benefits.  

We know how to deliver proficient quality assurance, validation and engineering services to make you feel confident with your products safety.

Job Description

o Responsibility for customers Computerized System Validation project management.

o Performs risk assessment and validation to verify compliance to regulations  (FDA CFR Part 11, EU annex 11) and user requirements.

o Performs software quality assurance tests (SQA).

o Provide quality support and guidance to operation, qualification, validation, monitoring and maintenance of computerized systems.

o Write SOP in the field of Data Integrity, SQA, and SDLC.

Work Environment

o Hybrid – Offices are located at Haifa

o On-site visits to customer sites.

Technical Skills

o Technical orientation and knowledge in SW and HW.

o Knowledge in SW testing methodologies is advantage.

o Project Management Skills

Required Education

o Bachelor’s Degree in: Engineering, Computer Science, Life Sciences, or a related field.

Soft Skills

o Detail-oriented with strong analytical and problem-solving skills.

o High level of integrity and commitment to compliance.

o Proactive mindset, eager to drive projects and champion quality initiatives.

o Adaptability and resilience in a fast-paced, regulated environment.

o Strong sense of accountability and ownership of deliverables.

o Excellent communication and interpersonal skills.