Senior Post Market Quality Engineer
HologicNewark, Delaware, United States • Marlborough, Massachusetts, United States
Posted October 8, 2025
92200 - 144300 USD year
Full Time
About the Company
Hologic is an innovative medical technology company dedicated to enabling healthier lives through groundbreaking products and services. Specializing in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions, the company excels in early detection and treatment of health conditions, driven by a commitment to women's health and a focus on clinical superiority. Hologic fosters a culture of expertise, dedication, and continuous improvement to meet unmet health needs globally.
Job Description
Hologic is seeking a Senior Post-Market Quality Engineer to lead quality engineering efforts for on-market medical devices. This role involves evaluating post-market feedback, investigating complaints, conducting risk assessments, and leading cross-functional teams to improve product performance. The role requires onsite presence and requires experience with FDA regulations and risk management.
Requirements
- Bachelor’s degree in Engineering (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 (Design Control, ISO 13485, EU Medical Device Regulation, ISO 14971, Risk Management, GMP, and GDP)
- Proven ability to lead teams and own critical tasks
- Expertise in reviewing and assessing product/project documentation
- Advanced proficiency with root cause analysis tools
- Exceptional communication and presentation skills
Benefits
- Competitive salary
- Annual bonus scheme