Senior Product Quality Engineer - FDA-Regulated Devices

Hologic; Town of Newark (WI); On-site; USD 119,000 - 187,000; Full time

Job summary

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

Qualifications

• Bachelor's degree required in Mechanical, Biomedical, Biomechanical, or Electrical Engineering.
• 8+ years’ experience in an FDA-regulated industry; 6+ years with a master's; 3+ years with a PhD.
• Demonstrated experience leading root cause analysis and complex complaint investigations; experience in product development/R&D is beneficial.

Responsibilities

• Serve as the product expert for assigned product lines and develop deep knowledge of product design, functionality, clinical use, and risk management documentation.
• Serve as process owner for Product Quality Engineering processes, ensuring compliance and effectiveness; provide training to engineers.
• Coach/mirror engineers on complaint investigations, risk management, test method validation, and documentation.

Skills

FDA Quality System Regulation

Design Control

Root Cause Analysis

CAPA

Risk Management

GMP

GDP

Project Leadership

Mentoring

Communication

Education

Bachelor’s Degree in Engineering

Job description

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