Senior Risk Management Quality Engineer (Medical Devices)

Hologic, Inc.; San Diego (CA); On-site; USD 120,100 - 188,000; Full time

Benefits offered by this job

Comprehensive training

Career development opportunities

Bonus eligible

Job summary

Hologic, Inc. is looking for a Quality Engineer Level 4 specializing in Risk Management. This senior role includes leading risk management activities and providing technical leadership through the product lifecycle.

As a vital team member, you will work collaboratively across various departments, ensuring effective risk management practices. Candidates should have substantial experience within the medical device or IVD industries, focusing on compliance and quality engineering principles.

We offer competitive salaries and dedication to employee development. Join us to help improve patient safety and product quality.

Qualifications

• Expertise in medical device risk management principles.
• Proven ability to mentor less experienced engineers.
• Experience leading cross-functional teams on risk management.

Responsibilities

• Lead risk management activities across project lifecycles.
• Develop and maintain risk management files and quality deliverables.
• Support audits and regulatory inspections.

Skills

Leading complex product, process, and quality system risk assessments

Strong technical judgment

Cross-functional facilitation skills

Assessing post-market data

Problem-solving skills

Education

Significant experience in quality engineering or risk management within the medical device industry

Tools

FMEA

Hazard analysis

Fault tree analysis

Job description

Hologic, Inc. is looking for a Quality Engineer Level 4 specializing in Risk Management. This senior role includes leading risk management activities and providing technical leadership through the product lifecycle.

As a vital team member, you will work collaboratively across various departments, ensuring effective risk management practices. Candidates should have substantial experience within the medical device or IVD industries, focusing on compliance and quality engineering principles.

We offer competitive salaries and dedication to employee development. Join us to help improve patient safety and product quality.