Hologic, Inc. · 2 weeks ago
Quality Assurance Engineer 2
Marlborough, MA
Full-time
Onsite
Entry, Mid Level
$78K/yr - $122K/yr
2+ years expHologic, Inc. is seeking a Quality Assurance Engineer – Product Quality to ensure the safety and reliability of life-saving medical devices. The role involves managing product holds, stop ships, and corrections, while developing and maintaining Quality Management System procedures and collaborating with cross-functional teams to drive process improvements.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
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
Qualification
Required
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
Benefits
Comprehensive training
Continued development and training
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase