Senior Risk Management Quality Engineer - Medical Devices

Hologic, Inc.; San Diego (CA); On-site; USD 98,500 - 154,000; Full time

Job summary

Hologic, Inc. is seeking an experienced Quality Engineer Level 3 in San Diego, California. The successful candidate will manage risk management activities for medical devices and diagnostics, ensuring compliance with various regulatory standards.

Key responsibilities include collaborating with teams across Quality, Regulatory Affairs, and Manufacturing, along with maintaining documentation for risk assessments. The annual salary ranges from $98,500 to $154,000, with bonus eligibility and comprehensive training provided.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related field.
• 5+ years of experience in a regulated medical device environment.
• Hands-on experience with risk management files and CAPA processes.

Responsibilities

• Perform product and process risk management activities.
• Collaborate with cross-functional teams for risk assessments.
• Ensure compliance with FDA regulations and ISO standards.

Skills

Risk management principles for medical devices

FDA Quality System requirements

ISO 13485 requirements

Complaints handling

Root cause analysis

Education

Bachelor's degree in engineering or related field

5+ years of experience in regulated environments

Job description

Hologic, Inc. is seeking an experienced Quality Engineer Level 3 in San Diego, California. The successful candidate will manage risk management activities for medical devices and diagnostics, ensuring compliance with various regulatory standards.

Key responsibilities include collaborating with teams across Quality, Regulatory Affairs, and Manufacturing, along with maintaining documentation for risk assessments. The annual salary ranges from $98,500 to $154,000, with bonus eligibility and comprehensive training provided.