Hologic, Inc. · 8 hours ago
Quality Engineer 2
Marlborough, MA
Full-time
Onsite
Entry, Mid Level
$77K/yr - $120K/yr
2+ years expHologic, Inc. is dedicated to ensuring the highest quality standards for life-saving medical devices. They are seeking a Quality Engineer II to drive compliance and continuous improvement, collaborating with teams to lead investigations and support design transfers while ensuring regulatory compliance and product quality.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Drive compliance, risk management, and continuous improvement across our product lifecycle
Collaborate with cross-functional teams to lead investigations, implement corrective actions, and support design transfers
Lead Nonconforming Events (NCE) investigations and CAPA teams to identify root causes, implement sustainable solutions, and maintain compliance
Prepare and review technical reports, validation documentation, and quality records
Compile, interpret, and act on quality system metrics and product quality data to drive improvements
Facilitate design transfers and manage seamless product transitions between sites during New Product Introduction (NPI)
Develop and maintain process FMEAs throughout the production lifecycle
Qualification
Required
In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product quality
Strong understanding of risk management principles, including ISO 14971 and PFMEA, to support design transfer and production processes
Familiarity with statistical tools and methodologies such as Six Sigma, Statistical Process Control (SPC), and Design of Experiments (DOE)
Proficient in Quality Management Systems (QMS), data analysis tools, and enterprise software systems
Proven ability to lead Nonconforming Events (NCE) investigations and CAPA teams to identify root causes, implement sustainable solutions, and maintain compliance
Strong technical writing skills for preparing and reviewing technical reports, validation documentation, and quality records
Analytical skills to compile, interpret, and act on quality system metrics and product quality data to drive improvements
Ability to facilitate design transfers and manage seamless product transitions between sites during New Product Introduction (NPI)
Proficient in developing and maintaining process FMEAs throughout the production lifecycle
Strong communication and collaboration skills to work effectively across teams and with stakeholders
Ownership-driven, taking accountability for deliverables and maintaining a proactive approach to resolving quality issues
Collaborative and team-oriented, fostering partnerships to achieve shared goals and deliver exceptional results
Customer-focused, with a commitment to exceeding expectations and delivering innovative, high-quality solutions
Continuous improvement mindset, driving operational excellence and lean thinking across the organization
Detail-oriented and compliance-focused, ensuring adherence to regulatory standards, company policies, and best practices
Bachelor's degree in a related discipline or equivalent combination of education and experience
2–4 years of experience as a Quality Professional in the medical device industry or equivalent combination of education and experience
Hands-on experience with investigations, CAPAs, and process validations (IQ, OQ, PQ)
Proven success in utilizing statistical tools and methodologies to analyze data and improve processes
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
2026-01-01
Dallas Morning News
2025-12-26
Company data provided by crunchbase