Product Quality Engineer 1

Hologic•Newark, NJ

2d•Onsite

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

Bachelor’s Degree in Engineering (Mechanical, Electrical or Biomedical preferred)
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

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 and root cause analyses, including prioritization based on product risk, data trends, and strategic impact, and coordination/communication with stakeholders.
Perform data analysis and trending of complaints and failure modes; identify risk mitigations and prepare/present findings and recommendations to internal stakeholders and Leadership.
Partner with cross-functional teams to perform Health Risk Assessments, determine need for CAPAs, recommend and scope changes, and implement design/process updates (drawings, fixtures/tooling, testing, and change control documentation).
Develop and improve testing methods used for complaint investigations and root cause activities and provide technical support to the complaint intake and PMQA field investigation teams.
Assess product changes for impact on design and risk management, define required supporting documentation, and provide post-market feedback to Operations, Engineering, and R&D to improve current and future products.
Support quality system activities including product quality metrics reporting, internal and external audits (facility, supplier, Notified Body, FDA), and monthly Quality Investigation Review Boards while applying company policies and procedures.