Hologic, Inc. · 3 hours ago
Quality Engineer 2
Marlborough, MA
Full-time
Onsite
Entry, Mid Level
$78K/yr - $122K/yr
2+ years expHologic, Inc. is seeking a Quality Engineer II to lead root cause analysis and resolve product complaints for medical devices. This role involves collaboration with various teams to enhance product reliability and serviceability, focusing on delivering quality outcomes that improve customer experience.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead root cause analysis and resolve product complaints for electromechanical in vitro diagnostic (IVD) devices
Collaborate with design, manufacturing, and service teams to translate customer feedback into actionable solutions
Drive post-market improvements for product reliability, durability, and serviceability
Maintain audit-ready records and compliance documentation
Implement process and design improvements that reduce field failures and enhance serviceability
Qualification
Required
Expertise in complaint investigations, root cause analysis, and sustaining engineering for medical devices
Strong understanding of Quality Management Systems (QMS), CAPA processes, and regulatory requirements, including ISO 13485 and FDA QMSR
Familiarity with reliability and systems engineering principles
Awareness of post-market surveillance and continuous improvement methodologies, such as 5S
Proven ability to lead root cause investigations and drive resolution of systemic quality issues through closed-loop improvement
Strong analytical skills for identifying trends, evaluating data, and developing actionable solutions
Effective communication skills to collaborate with cross-functional teams and present findings to stakeholders
Exceptional organizational and documentation skills to maintain audit-ready records and compliance documentation
Ability to implement process and design improvements that reduce field failures and enhance serviceability
Commitment to customer-focused solutions, ensuring product reliability and satisfaction
Bachelor's degree in engineering or a related technical field
2–4 years of experience in quality, reliability, or systems engineering within the medical device or related regulated industry
Hands-on experience with complaint investigations, CAPA processes, and sustaining engineering
Proven track record of supporting regulatory audits and maintaining audit-ready documentation
Preferred
Knowledge of ASQ certifications (CQE, CRE) and other quality/reliability standards
Experience with lean methodologies and statistical tools for continuous improvement
Experience with lean/continuous improvement methodologies such as 5S
ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), or similar certification
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
2026-01-17
Company data provided by crunchbase