Quality Engineer 1

Hologic • Newark, DE

6h • $78,000 - $122,100

About The Position

Are you passionate about ensuring the quality and reliability of life-saving medical devices? 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 required in either Mechanical, Biomedical, Biomechanical, or Electrical Engineering with 0-2 years experience
• Experience in an FDA regulated industry preferred
• Experience in root cause analysis or product development/R&D is beneficial
• Familiarity with FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP
• Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
• 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

• 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

• 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

Benefits

• We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so 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