Product Quality Engineer 3

Hologic•Newark, NJ

About The Position

Hologic is a global medical technology company focused on women’s health and wellbeing. Our Newark, Delaware team manufactures the 3Dimensions 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. Job Summary: 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.

Requirements

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.

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 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.