Quality Engineer

Hologic • San Diego, CA

134d • $69,000 - $101,100

About The Position

Are you an aspiring quality professional looking to start or grow your career in the medical device industry? At Hologic, we are seeking a Quality Engineer to support validation efforts, risk management, and compliance within our Quality Management System. In this role, you'll assist with process validations, equipment qualifications, and risk assessments while contributing to cross-functional teams for new product introductions and sustaining projects. If you're detail-oriented, eager to learn, and excited to contribute to the delivery of life-changing healthcare products, we encourage you to apply and be part of our mission to improve lives worldwide!

Requirements

• 0-2 years of experience in a diagnostic, medical device, biotech, or pharmaceutical company.
• Foundational understanding of validation methods, including process validation, analytical method validation, cleaning validation, and equipment/facility qualifications.
• Basic knowledge of risk analysis techniques, such as PFMEA and process risk assessments.
• Familiarity with regulatory requirements, including 21 CFR Part 820, ISO 13485, ISO 14971, and 21 CFR Part 11.
• Understanding of statistics, Statistical Process Control (SPC), and acceptance sampling methods.

Nice To Haves

• Exposure to validation activities, including process validation and equipment qualification.
• Familiarity with Quality Management Systems and regulated environments.

Responsibilities

• Assist with process validations, equipment qualifications, and risk assessments.
• Contribute to cross-functional teams for new product introductions and sustaining projects.
• Author and execute validation protocols, master validation plans, and reports under supervision.
• Maintain validation records and evaluate process specifications.

Benefits

• Comprehensive training upon joining and continued development throughout your career.
• Bonus eligibility based on performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree