Product Quality Engineer

Hologic • Newark, NJ

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About The Position

Are you passionate about driving product quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic’s Breast and Skeletal Health Division as a Product Quality Engineer and play a pivotal role in supporting on-market devices through rigorous investigation, root cause analysis, and collaborative problem-solving. At Hologic, our purpose is to enable healthier lives everywhere, every day. We’re looking for a Product Quality Engineer to support the quality of our on-market medical devices, helping ensure the safety and performance of products used in real clinical environments. This is an excellent opportunity for an early-career engineer to build experience in a regulated, FDA‑controlled environment and grow within a global medical device organization.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering (required).
• 0–2 years of experience (internships/co-ops welcome).
• Experience in an FDA-regulated industry is preferred.
• Exposure to root cause analysis or product development/R&D is a plus.
• Familiarity (or strong interest in learning) FDA Quality System Regulations, ISO 13485, risk management (ISO 14971), GMP, and GDP.
• Ability to work effectively on cross-functional project teams and take ownership of critical tasks.
• Strong analytical and problem-solving skills; familiarity with root cause tools (e.g., for complaints, NCs, CAPAs) is a plus.
• Good written and verbal communication and presentation skills.

Nice To Haves

• Exposure to test method validation, failure analysis, statistics, and design of experiments.
• Familiarity with reliability, electrical safety, sterilization, packaging, or biocompatibility standards.
• Understanding of verification/validation requirements and risk-based/statistical analysis concepts.

Responsibilities

• Own complaint investigations and associated root cause analysis, coordinating with cross-functional stakeholders.
• Support risk assessments and Health Risk Assessments, helping define problem statements and evaluate impact.
• Analyze and trend complaint and failure mode data; prepare and present findings to internal stakeholders.
• Participate in implementing design or process improvements (e.g., drawings, fixtures/tooling, testing, change control).
• Help develop or improve test methods used during complaint investigations.
• Provide technical support to the complaint intake team and Post-Market Quality Assurance (PMQA) team.
• Support customer site investigations as needed to resolve field quality issues.
• Contribute to preparation of product quality metrics and participate in internal and external audits.
• Provide post-market feedback to Operations, Engineering, and R&D to improve product design and manufacturing.

Benefits

• We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
• We provide comprehensive training when you join as well as continued development and training throughout your career.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level