Senior Product Quality Engineer

Hologic • Newark, DE

2d

About The Position

Hologic is dedicated to enabling healthier lives everywhere, every day—and the quality of our on‑market medical devices is central to that mission. We’re looking for a Senior Product Quality Engineer to lead post‑market product quality efforts by driving complaint investigations, root cause analysis, and implementation of corrective and preventive actions. In this role, you’ll own complex investigations, perform health risk assessments, lead cross‑functional teams to implement design and process changes, and provide data‑driven insights that improve product performance in the field. If you’re a technically strong, proactive engineer who enjoys solving real‑world quality issues and partnering across the business, this role is for you.

Requirements

• Working knowledge of FDA Quality System Regulations (21 CFR 820), especially Design Control requirements.
• Familiarity with ISO 13485, EU Medical Device Regulation (MDR), ISO 14971 (Risk Management), GMP, and GDP.
• Strong understanding of root cause analysis tools and their application to complaints, nonconformances (NCs), and CAPAs.
• Ability to lead and own investigations into post‑market complaints, including structured root cause analysis and effective stakeholder coordination and communication.
• Strong data analysis skills to trend complaint data and failure modes, identify threshold risks, propose mitigations, and prepare clear summaries for leadership.
• Proven capability to lead cross‑functional teams in implementing improvements or corrections, including design and process changes (drawing updates, fixtures, tooling, testing, and change control documentation).
• Skilled in developing or improving testing methods used during complaint investigation and root cause activities.
• Proficient in executing and documenting Health Risk Assessments for on‑market products, clearly defining problem, impact, and risk.
• Able to assess product changes for impact on design and risk management, and determine the supporting information required for implementation.
• Excellent communication and presentation skills to share product quality metrics, explain root causes, and recommend actions/resolutions to leadership.
• Comfortable training and supporting complaint intake teams by providing technical expertise for complex investigations.
• Operates with a high degree of autonomy and independence, requiring only minor oversight even on complex problems.
• Detail‑oriented and compliance‑focused, acting as an advocate for regulatory and quality system requirements in documentation and decision‑making.
• Proactive and results‑driven, urgently identifying and resolving field quality issues while upholding the Hologic brand image and values.
• Collaborative team player who builds strong relationships with Operations, Engineering, R&D, Sales, and Service.
• Analytical and systematic problem‑solver, committed to identifying true root causes and implementing sustainable corrective actions.
• Confident representing investigations and post‑market quality activities in internal and external audits (facility, supplier, Notified Body, FDA).
• Bachelor’s Degree in Engineering required (Mechanical, Electrical, Biomedical preferred).
• 5+ years of experience with a Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering.
• Or 1–3 years with a Master’s degree, or 0–1 year with a PhD in a related discipline.
• Experience in an FDA‑regulated industry (medical devices strongly preferred).

Nice To Haves

• Knowledge of test method validation, root cause failure analysis, statistical methods, and Design of Experiments (DOE).
• Familiarity with Reliability, Electrical Safety, Sterilization, Packaging, and Biocompatibility standards and requirements.
• Working knowledge of verification and validation requirements for regulated products.
• Familiarity with requirements analysis and development of testable, measurable specifications.
• Understanding of risk‑based and statistical analysis concepts.
• Hands‑on experience in root cause analysis, product development, or R&D, particularly for complex devices/systems.
• Experience participating in internal and external audits and inspections is a plus.

Responsibilities

• Lead post‑market product quality efforts by driving complaint investigations, root cause analysis, and implementation of corrective and preventive actions.
• Own complex investigations
• Perform health risk assessments
• Lead cross‑functional teams to implement design and process changes
• Provide data‑driven insights that improve product performance in the field.

Benefits

• comprehensive training when you join as well as continued development and training throughout your career

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level