Hologic, Inc. · 1 hour ago
Senior Post Market Quality Engineer
Newark, DE
Full-time
Hybrid
Mid, Senior Level
$92K/yr - $144K/yr
5+ years expHologic, Inc. is a company committed to empowering talent and fostering professional growth. They are seeking a Senior Post Market Quality Engineer to lead quality engineering efforts for on-market medical devices, focusing on complaint investigations, risk assessments, and implementing improvements based on findings.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Prioritize and own complaint investigations and risk assessments using data analysis, trending, and strategic impact
Lead root cause analyses and direct communication with stakeholders across the organization
Own Health Risk Assessments and drive efficient evaluation of on-market products
Lead cross-functional teams to implement improvements and corrective actions resulting from complaint investigations
Own and lead data analysis and trending of complaints and failure modes, identifying mitigations and presenting findings to internal stakeholders
Lead projects to implement design and process changes, including documentation, testing, and change control
Develop and optimize testing methods for complaint investigations and root cause analysis
Own training and technical guidance for the complaint intake team on complex investigations
Assess product changes for impact on design and risk management, and define supporting documentation requirements
Provide post-market feedback and insights to Operations, Engineering, and R&D to drive product improvement
Apply advanced judgment and expertise to resolve quality issues, ensuring compliance with company policies and procedures
Own on-site investigations at customer locations, leading resolution of field quality issues and upholding the Hologic brand
Present product quality metrics, root cause analyses, and recommendations to Leadership
Lead and participate in internal and external audits, including facility, supplier, Notified Body, and FDA inspections
Own preparation and presentation of materials for monthly Quality Investigation Review boards
Qualification
Required
Bachelor's degree in Engineering required (Mechanical, Electrical, Biomedical, or Biomechanical preferred)
5+ years of engineering experience in an FDA-regulated industry
Demonstrated leadership in root cause analysis, complaint investigation, and product development/R&D
Deep working knowledge of FDA Quality System Regulations (especially Design Control), ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP
Proven ability to lead teams and own critical tasks to ensure timely and effective resolution
Expertise in reviewing and assessing product/project documentation for compliance, and communicating findings to stakeholders
Advanced proficiency with root cause analysis tools; able to lead investigations for complaints, non-conformances (NCs), and CAPAs
Exceptional communication and presentation skills
Demonstrates strong autonomy, leadership, and ownership in solving complex problems
Benefits
Comprehensive training
Annual bonus scheme
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