Overview In this role you provide product quality engineering support for on-market medical devices, leading investigations, risk assessments, and root-cause analyses of post-market feedback. You will coordinate cross-functional teams to implement improvements, drive CAPAs, and ensure timely resolution of field quality issues while upholding the Hologic brand. You'll work closely with Operations, Engineering and R&D to improve device design and manufacturing in the field and development programs. This position offers a view into regulatory-compliant quality systems and continuous improvement at scale.
Compensation / Benefits- bonus eligible
- base salary with variable component
- comprehensive training and development
Responsibilities- Prioritize complaints and investigations based on product risk and data trends
- Own investigations and root-cause analysis with cross-functional collaboration
- Determine need for CAPA and scope changes for implementation
- Execute Health Risk Assessments and coordinate with internal teams
- Lead cross-functional teams to implement improvements from investigations
- Perform data analysis and trend complaints and failure modes, present findings
- Lead design/process change projects including documentation and testing
- Develop/improve testing methods for investigations and root-cause activities
- Train complaint intake team on technical aspects of investigations
- Assess product changes for impact on design and risk management
- Provide post-market feedback to Operations, Engineering and R&D
- Support field investigations and audits (FDA, Notified Bodies) and participate in Quality Investigation Review boards
- Present product quality metrics to Leadership and recommend actions
Key requirements- Bachelor's degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering (2-5 years experience)
- Experience in FDA-regulated industry preferred
- Experience in root cause analysis or product development/R&D beneficial
- Knowledge of RCA tools and CAPA processes
- Strong communication and presentation skills
- Ability to work on cross-functional teams and lead critical tasks
- Autonomy with analytical problem solving and data-driven decision making
- Strong communication skills
- Cross-functional collaboration
- Problem solving and analytical thinking
- FDA Quality System Regulations, Design Control, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, GDP
- Root cause analysis tools
- CAPA management
