Quality Assurance Engineer 2

Hologic Careers•Marlborough, MA

10h•$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. Knowledge: 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. Skills: 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. Behaviors: Proactive and detail-oriented, ensuring timely execution of quality processes and compliance with regulatory requirements. Collaborative and team-oriented, building strong partnerships across functions to drive results. Problem-solving mindset, with a focus on continuous improvement and operational efficiency. Results-driven, with the ability to manage escalations and adverse trends effectively. Adaptable and resilient, thriving in a fast-paced, regulated environment.

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.
Proactive and detail-oriented, ensuring timely execution of quality processes and compliance with regulatory requirements.
Collaborative and team-oriented, building strong partnerships across functions to drive results.
Problem-solving mindset, with a focus on continuous improvement and operational efficiency.
Results-driven, with the ability to manage escalations and adverse trends effectively.
Adaptable and resilient, thriving in a fast-paced, regulated environment.
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.