Product Quality Engineer Date Posted:

29 September 2026

Closing Date:

October 29, 2026

Recruiter:

Hologic Location:

Newark, Delaware Salary:

USD120,000

to

USD150,000

Job Type & Industry:

Technology Risk Contract Type:

Permanent Job Reference:

2992009483-2 Apply for this job now Job Description Hologic is seeking a Product Quality Engineer 3 to ensure the safety, reliability, and performance of our diagnostic and imaging solutions that advance women's health. In this role, you will lead product quality activities across the lifecycle, including design reviews, verification and validation, risk management, and process validation. You will drive root cause investigations, CAPA, and nonconformance resolution for manufacturing and field issues while ensuring compliance with

FDA, ISO

13485, and internal quality systems. Partnering closely with R D, manufacturing, and regulatory teams, you will develop test methods, analyze data using statistical tools, and support product launches and sustaining engineering. At Hologic, you'll join a mission-driven, collaborative culture that offers continuous learning, exposure to cutting-edge medical technologies, and global career growth opportunities, all while improving patient outcomes worldwide. Responsibilities Ensure product quality for diagnostic and imaging systems through design reviews, validation, and risk analysis Lead root cause investigations, CAPA, and nonconformance resolution for manufacturing and field issues Develop and execute test methods, protocols, and statistical analysis to verify product performance and reliability Partner with R D, manufacturing, and regulatory teams to align products with FDA, ISO, and quality system requirements Support process validations and continuous improvement initiatives using Six Sigma and Lean tools Author and maintain technical documentation, inspection plans, and quality reports Provide quality engineering support for product launches, change control, and sustaining engineering projects Train cross-functional teams on quality standards, procedures, and best practices Required Skills Quality engineering in medical devices or biotech Design Verification & Validation (DV&V) Statistical analysis (Minitab or similar) Root cause analysis and CAPARisk management (FMEA, ISO 14971) Process validation (IQ/OQ/PQ) Regulated environment experience (FDA, ISO 13485) Technical documentation and report writing Lean/Six Sigma methodologies Cross-functional collaboration and communication