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Senior Product Quality Engineer - FDA-Regulated Devices

Job in Town of Newark, Rock County, Wisconsin, USA
Listing for: Hologic
Full Time position
Listed on 2026-11-04
Job specializations:
  • Engineering
    Quality Engineering, Biomedical Engineer, Regulatory Compliance Specialist
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 119000 - 187000 USD Yearly USD 119000.00 187000.00 YEAR
Job Description & How to Apply Below
Location: Town of Newark

Hologic is seeking an experienced quality engineering leader to act as the product expert for assigned lines and drive compliance with FDA quality systems, ISO 13485, and related standards. You will mentor engineers in root cause investigations, risk assessments, CAPAs, and validation activities while coordinating cross-functional investigations and changes.

The role requires deep knowledge of Design Control, risk management, and problem-solving across complex complaints, with ongoing

Our team is growing, and we are hiring a Senior Product Quality Engineer - FDA-Regulated Devices in Town of Newark, WI, United States.

We invite applications for the Senior Product Quality Engineer - FDA-Regulated Devices position located in Town of Newark, WI, United States.

The following position is for a Senior Product Quality Engineer - FDA-Regulated Devices with Hologic.

This position is for the Senior Product Quality Engineer - FDA-Regulated Devices role at Hologic.

Position Requirements
10+ Years work experience
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