Quality Systems Specialist - Hybrid

The Quality System Specialist supports the migration, digitization, and consolidation of legacy product design and technical documentation into the company's electronic Quality Management System (eQMS) in alignment with IVDR requirements. This role works cross-functionally to ensure documentation completeness, accuracy, and compliance with global quality standards.

Key Responsibilities:

Digitize and migrate legacy design, development, and technical files into eQMS and regulatory databases Verify document metadata accuracy and ensure proper linkage to DHF and IVDR Technical Files Coordinate with cross-functional teams to gather required documentation and close data gaps Conduct gap assessments on legacy documentation against IVDR and quality system requirements Support ongoing IVDR documentation updates, scanning, and archiving activities

Qualifications:

1-3 years of experience in a regulated manufacturing environment (medical device/pharma preferred) Basic knowledge of GMP and quality systems Experience with eQMS tools (e.g., EtQ, Veeva) is a plus Strong attention to detail, organization, and multitasking ability Proficiency in Microsoft Office tools

Core Competencies:

Documentation control & data integrity Cross-functional collaboration Ability to work independently in a fast-paced, evolving environment #

GRPA Pay:

$35.00 - $40.00 per hour

Work Location:

In person