Quality Management Office Specialist - Remote

Overview

This position aims to provide quality management, control, assurance, and compliance with the development process of Saama products and services.

In Short

• Ensures compliance with regulations (e.g., FDA, GDPR) and ICH guidelines.
• Supports Design Assurance Engineer/Product Quality Engineer.
• Reviews development and technical documentation.
• Participates in Risk Management throughout the product life cycle.
• Contributes to review of product and service information.
• Supervises quality assurance activities in production and process control.
• Organizes inspections and testing techniques for products.
• Performs quality checks on design control and production documentation.
• Supports Validation activities to ensure intended use.
• Provides quality and compliance expertise throughout the project life cycle.

Requirements

• Bachelor's degree in computer sciences, health/life sciences, or equivalent.
• 6+ years of experience with Design Controls and Quality Management systems.
• 5+ years working in cGMP and/or GCP-regulated environments.
• Knowledge of GAMP5 and CSA guidelines.
• Good troubleshooting and communication skills.
• Experience managing CAPAs and complaints.
• Excellent skills in analyzing issues and processes.
• Strong interpersonal and communication skills.
• Detail-oriented and goal-oriented.
• Ability to manage multiple tasks effectively.

Benefits

• Remote work with occasional travel.
• Opportunity to work in a collaborative environment.
• Professional development and training opportunities.
• Engagement in innovative projects.
• Supportive team culture.