Description

The Quality Assurance Associate is responsible for supporting and maintaining the Quality Assurance programs and Quality Systems at the Hopkinton site. This fully on-site position plays a critical role in ensuring compliance with the company’s Quality Management System (QMS) and applicable regulatory requirements. The individual will collaborate cross-functionally to support manufacturing operations, regulatory activities, and continuous quality improvement initiatives in a regulated medical device environment. Duties include ensuring compliance with established requirements, maintaining quality records, administering the Document Control System, participating in communications with regulatory authorities, conducting internal audits, supporting quality initiatives and other duties as assigned.

Requirements

Bachelor of Science (B.S.) degree in a science-related field or equivalent experience in an FDA-regulated industry preferred. Experience working within a Quality System preferred. Experience conducting internal and external audits preferred. Knowledge of medical device regulations and quality assurance principles preferred. Strong verbal and written communication skills. Computer proficiency required. Ability to communicate effectively at multiple levels within an organization. Strong organizational skills with the ability to prioritize tasks, establish goals, and maintain accurate records.

Quality Systems Associate

Description

Requirements

ISTO Biologics