Quality Engineer 1 at Hologic, Inc.

Newark, Delaware, United States -

Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

122100.0

Posted On

14 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Complaint Investigations, Root Cause Analysis, Corrective And Preventive Actions, Risk Management, Compliance, Process Improvements, Design Control, Statistical Methods, Test Method Validation, Design Of Experiments, Biocompatibility, Verification, Validation, Requirements Analysis, Communication, Presentation

Industry

Medical Equipment Manufacturing

Description

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. Knowledge: • Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP. • Familiarity with root cause analysis tools, risk management principles, and compliance frameworks. • Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility. 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. 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 Behaviors • 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. Why join Hologic? 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. The annualized base salary range for this role is $78,000-$122,100 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, 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, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-AV1

Responsibilities

This role involves leading complaint investigations, performing root cause analyses, and implementing corrective and preventive actions to enhance the quality and compliance of on-market medical devices. The engineer will collaborate with cross-functional teams to drive process improvements and assess risks to ensure patient safety.