Product Quality Engineer

Job Description

Hologic is a global medical technology company focused on women's health and wellbeing. Our Newark, Delaware team manufactures the 3

Dimensions Mammography System, recognized as the "Coolest Thing Made in Delaware," which helps detect breast cancer earlier and with greater certainty.

Join a high-growth, world-class manufacturing facility producing life-saving medical devices.

Product Quality Engineer will make a direct impact on patient safety and product excellence by serving as a key quality partner for on-market medical devices. In this role, you will investigate product performance issues and customer complaints, conduct risk assessments and root cause analyses, and drive data-based solutions that enhance product quality and reliability. Collaborating across Engineering, Manufacturing, Regulatory, and Quality teams, you will lead cross-functional efforts to implement corrective and preventive actions, ensuring continuous improvement and compliance throughout the product lifecycle.

This is an opportunity to influence meaningful change while helping deliver high-quality medical devices that improve patient outcomes.

In addition to other duties as business needs require, the Product Quality Engineer will:

• Lead complaint prioritization and investigations based on product risk, data trends, and business impact.
• Conduct root cause analyses and coordinate cross-functional teams to drive timely resolution of quality issues.
• Perform health risk assessments and evaluate product performance concerns for on-market medical devices.
• Partner with Quality, Operations, Engineering, R&D, Regulatory, and Manufacturing teams to determine corrective and preventive actions (CAPAs) and implement product or process improvements.
• Analyze and trend complaint and failure mode data, identify emerging risks, and present findings and recommendations to stakeholders and leadership.
• Manage design and process change projects, including testing, documentation, change control, and implementation activities.
• Develop and enhance investigation and testing methods to improve problem-solving effectiveness.
• Provide technical guidance and training to complaint handling and support teams.
• Assess the impact of product changes on design controls and risk management requirements.
• Partner with field-based teams to investigate customer-site quality issues and ensure timely resolution.
• Present quality metrics, investigation outcomes, and recommendations to leadership and review boards.
• Support internal and external audits, including supplier audits and regulatory inspections.
• Apply professional expertise to independently resolve complex quality issues while contributing to continuous improvement initiatives.

• Working knowledge of 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
• Strong knowledge of root cause analysis tools and ability to lead root cause activities for complaint investigations, NCs, CAPAs, etc.
• Excellent communication and presentation skills
• Works with high degree of autonomy and independence, requiring minor oversight on complex problems with analysis requiring a variety of factors.

• 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

The annualized base salary range for this role is $85,300- $133,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.