Product Quality Engineer 1

Hologic • Newark, DE

6h

About The Position

At Hologic, we are seeking a Product Quality Engineer 1 to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.

Requirements

• Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
• 0-2 years experience
• Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP
• Familiarity with root cause analysis tools, risk management principles, and compliance frameworks
• Ability to effectively work on project teams
• Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment
• Knowledge of root cause analysis tools and ability to effectively participate in root cause activities for complaint investigations, NCs, CAPAs, etc.
• Good communication and presentation skills
• Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements
• Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes
• Collaborative and team-oriented, building productive relationships across functions to drive quality improvements
• Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution
• Continuous improvement mindset, driving process optimization and identifying opportunities to enhance product quality

Nice To Haves

• Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility
• Experience in an FDA regulated industry
• Experience in root cause analysis or product development/R&D
• Familiarity with test method validation, root cause failure analysis, statistical methods, and design of experiment
• Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements
• Working knowledge of verification and validation requirements for a regulated product
• Familiarity with requirements analysis, including development of testable and measurable specifications
• Knowledge of risk based and statistical analysis concepts

Responsibilities

• Provide engineering support for on-market medical devices
• Lead complaint investigations
• Perform root cause analyses
• Implement corrective and preventive actions to improve product quality and compliance
• Collaborate with cross-functional teams
• Drive process improvements
• Assess risks
• Deliver impactful solutions that enhance patient safety and customer satisfaction
• Effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
• Appropriately assess written product and project documentation as an advocate for compliance, and effectively communicate assessment
• Effectively participate in root cause activities for complaint investigations, NCs, CAPAs, etc.

Benefits

• Comprehensive training when you join
• Continued development and training throughout your career
• Bonus eligible

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees