Quality Assurance Engineer 2

Hologic•Marlborough, MA

8d•$78,000 - $122,100

About The Position

Are you passionate about ensuring the safety and reliability of life-saving medical devices? At Hologic, we are seeking a Quality Assurance Engineer – Product Quality to play a critical role in managing product holds, stop ships, corrections, and field actions. In this role, you’ll develop and maintain Quality Management System (QMS) procedures, collaborate with cross-functional teams, and drive process improvements to ensure compliance and efficiency. If you’re detail-oriented, proactive, and eager to contribute to the continuous improvement of product quality, this is your opportunity to make a meaningful impact in the healthcare industry.

Requirements

Strong understanding of Quality Management Systems (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 best practices for tracking quality records.
Expertise in root cause analysis methodologies and corrective action processes.
Proven ability to develop, implement, and maintain QMS procedures and work instructions for product holds, stop ships, and corrections/removals.
Strong organizational skills to plan, execute, and monitor field actions, recalls, and corrective actions.
Effective communication skills to liaise with corporate process owners, external vendors, and cross-functional teams.
Technical writing skills for documenting progress, tracking closure of records, and creating training materials.
Ability to conduct complex investigations and provide clarity into root cause findings.
Proficiency in identifying process improvements and recommending enhancements to quality systems.
Experience in providing training, guidance, and ongoing support to ensure proper utilization of quality tools and systems.
2-4 years 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/removal activities.
Proven track record of 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.

Responsibilities

Manage product holds, stop ships, corrections, and field actions.
Develop and maintain Quality Management System (QMS) procedures.
Collaborate with cross-functional teams.
Drive process improvements to ensure compliance and efficiency.
Plan, execute, and monitor field actions, recalls, and corrective actions.
Liaise with corporate process owners, external vendors, and cross-functional teams.
Document progress, track closure of records, and create training materials.
Conduct complex investigations and provide clarity into root cause findings.
Identify process improvements and recommend enhancements to quality systems.
Provide training, guidance, and ongoing support to ensure proper utilization of quality tools and systems.