Hologic, Inc. · 1 day ago
Post Market Quality Engineer
Newark, DE
Full-time
Hybrid
Entry, Mid Level
$78K/yr - $122K/yr
2+ years expHologic, Inc. is a company dedicated to improving women's health through innovative medical devices. The Post Market Quality Engineer will be responsible for ensuring the quality and compliance of on-market medical devices through investigations, risk assessments, and cross-functional collaboration to implement improvements.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Prioritize complaints and investigations based on product risk, data analysis, and strategic impact
Own investigations and root cause analyses, collaborating and communicating with stakeholders
Execute Health Risk Assessments and coordinate evaluations of on-market products
Lead cross-functional teams to implement corrective actions and improvements based on investigation results
Analyze and trend data related to complaints and failures, identifying mitigation strategies and presenting findings to internal stakeholders
Lead projects to implement design or process changes, including drawing updates, fixture/tooling updates, testing, and change control documentation
Develop or improve testing methods used during complaint investigations and root cause activities
Train and support the complaint intake team with technical expertise
Assess product changes for impact to design and risk management, determining supporting information required for implementation
Provide post-market feedback to Operations, Engineering, and R&D to improve device design and manufacturing
Conduct field investigations in partnership with sales and service teams, ensuring timely resolution of field quality issues
Present product quality metrics to leadership, explaining root causes and recommending actions
Participate in internal and external audits, including FDA inspections and supplier audits
Support monthly Quality Investigation Review boards
Qualification
Required
Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering required
2–5 years' experience in engineering, ideally within an FDA-regulated industry
Experience in root cause analysis or product development/R&D is beneficial
Working knowledge of FDA Quality System Regulations, ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP
Strong ability to work on and lead project teams, ensuring timely and effective resolution of tasks
Skilled in assessing documentation for compliance and effectively communicating assessments
Experienced with root cause analysis tools and leading investigation activities (complaints, NCs, CAPAs)
Good communication and presentation skills
Ability to work with autonomy on complex problems, requiring analysis of a variety of factors
Preferred
Familiarity with test method validation, statistical methods, and design of experiment
Understanding of reliability, electrical safety, sterilization, packaging, and biocompatibility standards
Experience with verification and validation requirements for regulated products
Knowledge of requirements analysis, risk-based, and statistical analysis concepts
Benefits
Competitive salary
Annual bonus scheme
Comprehensive training
Continued development and training throughout your career
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