Lead Medical Device Risk & Quality Engineer

Hologic, Inc.; Louisville (CO); On-site; USD 110,000 - 130,000; Full time

Job summary

Hologic, Inc. is seeking a Lead Risk Management Quality Engineer in Louisville, CO.

This full-time, on-site role leads risk management across product development and lifecycle management, collaborating with R&D, Regulatory, Clinical, and Manufacturing to identify, assess, and mitigate risks. You will facilitate FMEA and hazard analyses, review design changes for risk impact, and provide guidance on risk management tools.

Qualifications

• Must have strong risk management and quality engineering skills.
• Proficiency with regulatory requirements (ISO 14971, ISO 13485, FDA QSR, EU MDR).

Responsibilities

• Facilitate risk analyses (FMEA, hazard analysis).
• Review design and process changes for risk impact.
• Provide guidance and training on risk management processes and tools.
• Support internal and external audits and continuous improvement.
• Collaborate with R&D, Regulatory Affairs, Clinical, and Manufacturing.

Skills

Risk management

Quality engineering

Regulatory knowledge

CAPA management

Change control

Design controls

Root cause analysis

Cross-functional collaboration

Communication skills

Project management

Education

Bachelor's degree in Engineering/Science

CQE/CQA/RAC certification (plus)

Tools

CAPA management

Change control

Design controls

Root cause analysis

Quality systems & data analysis

Job description

Hologic, Inc. is seeking a Lead Risk Management Quality Engineer in Louisville, CO.

This full-time, on-site role leads risk management across product development and lifecycle management, collaborating with R&D, Regulatory, Clinical, and Manufacturing to identify, assess, and mitigate risks. You will facilitate FMEA and hazard analyses, review design changes for risk impact, and provide guidance on risk management tools.