Senior Post Market Quality Engineer

Overview

Senior Post Market Quality Engineer – lead quality engineering efforts for on-market medical devices. Responsible for evaluating post-market feedback, investigating complaints, performing risk assessments and root cause analyses, and leading cross-functional teams to implement improvements based on investigation findings. Location options:
Newark, DE or Marlborough, MA. Onsite presence is required Monday through Thursday with a remote day on Friday.

• 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.

Education

• Bachelor’s degree in Engineering required (Mechanical, Electrical, Biomedical, or Biomechanical preferred).

Experience

• 5+ years of engineering experience in an FDA-regulated industry.
• Demonstrated leadership in root cause analysis, complaint investigation, and product development/R&D.

Skills

• 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.