Quality Assurance Specialist - Remote

Overview

The Quality Assurance Specialist is responsible for supporting DeepHealth products and product development, along with the Quality Management System throughout the organization. The Quality Assurance Specialist will be responsible for collaborating cross-functionally to support and guide product development.

In Short

• Work cross-functionally with Engineering, Clinical, and Marketing teams.
• Take ownership of product-specific Quality Management System processes.
• Integrate products from corporate and/or product acquisitions.
• Ensure compliance to US and OUS standards and regulations.
• Collaborate with the Quality Assurance team.
• Participate in regulatory audits.
• Provide QMS training.
• Manage complaints and CAPAs.
• Work with international teams.
• Support product development and design changes.

Requirements

• Bachelor’s degree in relevant field or equivalent experience.
• Strong knowledge of FDA Quality System Regulations.
• Knowledge of EU Medical Device Regulation (MDR).
• 5 - 8 years working in a regulated industry.
• Excellent written and oral communication skills.
• Knowledge of pre- and post-market clinical studies preferred.
• Participation in regulatory audits a plus.

Benefits

• Flexible work schedule.
• Ability to work remotely.
• Opportunity to support international teams.
• Work in a collaborative environment.