Product Quality Engineer 1

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.

Key Responsibilities

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

• 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.

Education

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

Experience

• 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

Skills

• 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.

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• Good communication and presentation skills

Preferred

• 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

Compensation

The annualized base salary range for this role is $55,000- $86,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Agency And Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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