Product Quality Engineer at Hologic, Inc.

Newark, Delaware, United States -

Full Time

Start Date

Immediate

Expiry Date

18 May, 26

Salary

102200.0

Posted On

17 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Root Cause Analysis, Risk Assessments, Data Analysis, Change Control, Test Method Development, Cross-functional Teamwork, Problem-Solving, Communication, FDA Quality System Regulations, ISO 13485, ISO 14971, GMP, GDP, Failure Analysis, Statistics, Verification

Industry

Medical Equipment Manufacturing

Description

Are you passionate about driving product quality and ensuring the safety and effectiveness of life-changing medical devices? Join Hologic’s Breast and Skeletal Health Division as a Product Quality Engineer and play a pivotal role in supporting on-market devices through rigorous investigation, root cause analysis, and collaborative problem-solving. At Hologic, our purpose is to enable healthier lives everywhere, every day. We’re looking for a Product Quality Engineer to support the quality of our on-market medical devices, helping ensure the safety and performance of products used in real clinical environments. This is an excellent opportunity for an early-career engineer to build experience in a regulated, FDA‑controlled environment and grow within a global medical device organization. What You’ll Do Own complaint investigations and associated root cause analysis, coordinating with cross-functional stakeholders. Support risk assessments and Health Risk Assessments, helping define problem statements and evaluate impact. Analyze and trend complaint and failure mode data; prepare and present findings to internal stakeholders. Participate in implementing design or process improvements (e.g., drawings, fixtures/tooling, testing, change control). Help develop or improve test methods used during complaint investigations. Provide technical support to the complaint intake team and Post-Market Quality Assurance (PMQA) team. Support customer site investigations as needed to resolve field quality issues. Contribute to preparation of product quality metrics and participate in internal and external audits. Provide post-market feedback to Operations, Engineering, and R&D to improve product design and manufacturing. What We’re Looking For Education Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering (required). Experience 0–2 years of experience (internships/co-ops welcome). Experience in an FDA-regulated industry is preferred. Exposure to root cause analysis or product development/R&D is a plus. Skills & Knowledge Familiarity (or strong interest in learning) FDA Quality System Regulations, ISO 13485, risk management (ISO 14971), GMP, and GDP. Ability to work effectively on cross-functional project teams and take ownership of critical tasks. Strong analytical and problem-solving skills; familiarity with root cause tools (e.g., for complaints, NCs, CAPAs) is a plus. Good written and verbal communication and presentation skills. Preferred (nice to have): Exposure to test method validation, failure analysis, statistics, and design of experiments. Familiarity with reliability, electrical safety, sterilization, packaging, or biocompatibility standards. Understanding of verification/validation requirements and risk-based/statistical analysis concepts. So why join Hologic? We are committed to making Hologic the company where top talent comes to grow. 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. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you. If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you! The annualized base salary range for this role is $65,300 - $102,200 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. As part of our commitment to a fair and accurate evaluation of each candidate's qualifications, we require all applicants to refrain from using AI tools, such as generative AI or automated writing assistance, during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process. Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans. #LI-NT1

Responsibilities

The Product Quality Engineer will own complaint investigations, conduct root cause analysis, and support risk assessments for on-market medical devices. They will also analyze failure data, participate in design/process improvements, and provide technical support to quality assurance teams.