Quality Assurance Engineer 3

Hologic•Marlborough, MA

18h•$97,600 - $152,700

About The Position

Hologic is seeking a Quality Assurance Engineer – Product Quality to manage product holds, stop ships, corrections, and field actions for medical devices. The role develops and maintains Quality Management System (QMS) procedures, collaborates with cross-functional teams, and drives process improvements to support compliance and operational efficiency. Responsibilities include planning and monitoring field actions, recalls, and corrective actions; conducting complex investigations and identifying root causes; documenting and tracking quality records; and providing training and support on quality tools and systems. The position contributes to the safety and reliability of medical devices in a regulated environment.

Requirements

2–4 years of experience in Quality Assurance, Project Management, or Customer Service roles in a medical device or related regulated industry.
Hands-on experience with field actions, product holds, stop-ship processes, and corrective or removal activities.
Experience supporting QMS initiatives, including integration and process improvements.
Experience conducting complex investigations and implementing corrective actions.
Familiarity with cross-functional collaboration on quality improvement projects.
Strong understanding of QMS and regulatory requirements, including field action management, product holds, and stop ships.
Familiarity with FDA regulations, ISO 13485 standards, and corrective/removal action processes.
Knowledge of product lifecycle management systems and quality-record tracking practices.
Expertise in root-cause analysis methodologies and corrective-action processes.
Strong organizational, communication, and technical writing skills.
Ability to identify process improvements and provide training and support.

Responsibilities

Develop, implement, and maintain QMS procedures and work instructions for product holds, stop ships, and corrections or removals.
Plan, execute, and monitor field actions, recalls, and corrective actions.
Collaborate with corporate process owners, external vendors, and cross-functional teams.
Document progress, track the closure of quality records, and create training materials.
Conduct complex investigations and clarify root-cause findings.
Identify process improvements and recommend enhancements to quality systems.
Provide training, guidance, and ongoing support to promote proper use of quality tools and systems.
Manage escalations and adverse trends effectively.