Lead Risk Management 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

Company Description

Hologic, Inc. is an innovative medical technology company dedicated to enabling healthier lives everywhere, every day, with a strong focus on advancing women’s health and well-being. The company’s clinically proven products in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions help detect, diagnose, and treat illnesses earlier and more effectively. Hologic’s global growth is driven by the expertise and commitment of its teams to deliver science-based certainty and address unmet health and wellness needs. By continually improving technology, education, and market access, Hologic aims to minimize doubt and maximize confidence for customers and their patients, setting a high standard of excellence in healthcare.

Role Description

The Lead Risk Management Quality Engineer is a full-time, on-site role based in Louisville, CO, responsible for driving risk management activities across product development and lifecycle management. This role leads the planning, execution, and maintenance of risk management files, ensuring compliance with applicable standards and regulations and alignment with Hologic’s quality system. The individual collaborates closely with cross-functional teams—including R&D, Regulatory Affairs, Clinical, and Manufacturing to identify, assess, and mitigate product risks, and to support design reviews and post-market surveillance. Typical responsibilities include facilitating risk analyses (such as FMEA and hazard analysis), reviewing design and process changes for risk impact, and providing guidance and training on risk management processes and tools. The Lead Risk Management Quality Engineer also supports internal and external audits, contributes to continuous improvement initiatives, and helps ensure that Hologic products meet high standards for safety, performance, and reliability.

Qualifications

• Strong risk management and quality engineering skills, including experience with FMEA, hazard analysis, risk control strategies, and product lifecycle risk documentation.
• Knowledge of medical device regulations and standards such as ISO 14971, ISO 13485, FDA QSR, and EU MDR, with the ability to apply regulatory requirements in practical, product-focused ways.
• Proficiency with quality systems and tools, including CAPA management, change control, design controls, root cause analysis, and data-driven decision-making.
• Solid technical background in engineering or science, with the ability to interpret design inputs, specifications, test methods, and manufacturing processes.
• Effective cross-functional collaboration and communication skills, with experience leading meetings, facilitating risk workshops, and influencing stakeholders at multiple levels.
• Demonstrated ability to manage multiple projects, prioritize tasks, and deliver high-quality work within timelines in a regulated environment.
• Bachelor’s degree in Engineering, Science, or a related technical discipline; advanced degree or relevant professional certifications (e.g., CQE, CQA, RAC) are a plus.
• Experience in medical