Hologic, Inc. · 3 months ago
Post Market Quality Engineer
Newark, DE, United States
Full-time
Hybrid
Entry, Mid Level
$72K/yr - $113K/yr
2+ years expHologic, Inc. is a company focused on providing quality engineering support for on-market medical devices. The Post Market Quality Engineer will evaluate post-market feedback, investigate complaints, perform risk assessments, and lead cross-functional teams to implement improvements based on investigation findings.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Prioritize complaints and investigations using product risk, data analysis, trending, and strategic impact
Own complaint investigations and associated root cause analyses, coordinating collaboration and communication with stakeholders
Partner with cross-functional teams to communicate findings, determine if CAPA is required, and scope recommended changes
Perform Health Risk Assessments and coordinate with internal teams to ensure efficient and effective evaluation of on-market products
Lead cross-functional teams in implementing improvements or corrections resulting from complaint investigations
Perform data analysis and trending of complaints and failure modes, identify mitigations for threshold risks, and prepare/present findings to internal stakeholders
Lead projects to implement design or process changes, including updating drawings, fixtures, tooling, testing, and change control documentation
Develop and improve testing methods used during complaint investigations and root cause activities
Train and support the complaint intake team by providing technical expertise for complex investigations
Assess product changes for impact on design and risk management, and determine supporting information required for implementation
Provide post-market feedback to Operations, Engineering, and R&D, leveraging complaint trends and other forums to drive continuous product improvement
Apply company policies and procedures to resolve a variety of issues, developing professional expertise and judgement
Perform on-site investigations at customer locations, collaborating with field-based teams (sales, service) to urgently resolve field quality issues while upholding the Hologic brand
Present product quality metrics to Leadership, explain root causes, and recommend actions/resolutions
Participate actively in internal and external audits, including facility, supplier, Notified Body, and FDA inspections
Support monthly Quality Investigation Review boards by preparing and presenting relevant materials
Travel to customer sites - 25% travel
Qualification
Required
Bachelor's degree in Engineering required (Mechanical, Electrical, Biomedical, or Biomechanical preferred)
2–5 years of experience in engineering, ideally within an FDA-regulated industry
Solid working knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP
Ability to work effectively on project teams, including leading critical tasks to ensure timely and appropriate resolution
Skilled at reviewing and assessing product/project documentation for compliance, with strong communication of findings and recommendations
Proficient with root cause analysis tools and techniques; able to lead investigations for complaints, non-conformances (NCs), and CAPAs
Strong communication and presentation skills
Demonstrates intermediate autonomy and independence, requiring minimal oversight when solving complex problems
Preferred
Experience in root cause analysis or product development/R&D is a plus
Benefits
Competitive salary and annual bonus scheme
Comprehensive training when you join as well as 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
2026-01-08
2026-01-07
Company data provided by crunchbase