Lead Product Quality Engineer

Hologic • Newark, DE

2d • $119,300 - $186,600

About The Position

Provide product quality engineering support for on-market medical devices and serve as the product expert for assigned product lines and processes. The role performs evaluations, investigations, risk assessments, and root cause analysis related to post-market feedback and field complaints. It leads cross-functional implementation of improvements or corrections based on investigation results and mentors Product Quality Engineers to strengthen technical capability and investigation quality.

The role also owns and maintains Product Quality Engineering processes and procedures, supports complaint intake training, analyzes complaint trends and failure modes, and communicates product-quality findings to internal stakeholders and leadership. It leads field investigations and participates in audits and inspections as a product subject matter expert. Other function-related activities may be assigned as reasonably required by business needs.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering, with 8+ years of experience; alternatively, 6+ years with a master’s degree or 3+ years with a PhD.
• Experience in an FDA-regulated industry.
• Demonstrated experience leading root cause analysis and complex complaint investigations.
• Demonstrated experience coaching, mentoring, or training engineers or technical staff.
• In-depth knowledge of FDA Quality Management System Regulation (21 CFR 820), especially Design Control requirements; ISO 13485; EU MDR 2017/745; ISO 14971 Risk Management; GMP; and GDP.
• Ability to lead project teams and take leadership on critical tasks to ensure timely completion or resolution.
• Ability to assess written product and project documentation for compliance and communicate assessments effectively.
• Strong knowledge of root cause analysis tools and ability to lead and coach root cause activities for complaint investigations, nonconformances, and CAPAs.
• Excellent communication and presentation skills, including ability to influence cross-functional partners.
• Strong coaching and mentoring skills and ability to develop technical capability in others.
• Ability to develop and maintain product knowledge and serve as subject matter expert for assigned product lines.
• Ability to manage multiple projects and priorities simultaneously.
• Ability to work autonomously with minimal oversight on highly complex problems involving analysis of multiple factors.

Nice To Haves

• Experience in product development or R&D.
• 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.
• ASQ Certified Quality Engineer (CQE) or equivalent.

Responsibilities

• Serve as product expert for assigned product lines, including knowledge of product design, functionality, clinical use, known failure modes, and risk-management documentation.
• Own Product Quality Engineering processes and procedures, ensuring compliance, effectiveness, and consistent application; provide process training and mentorship.
• Coach and mentor Product Quality Engineers on complaint investigations, root cause analysis, risk management, risk assessments, test method validation, and documentation; review documentation for technical quality and compliance.
• Guide prioritization, evaluation, and documentation of complaints and investigations according to product risk and timely completion needs.
• Drive consistency and best practices across the Product Quality Engineering team, including implementation of improvement opportunities, tools, technologies, and methods.
• Lead investigations and root cause analysis, coordinating stakeholder collaboration and communication.
• Partner with cross-functional teams to communicate root causes, determine whether CAPA is required, recommend changes, and scope implementation effort.
• Execute Health Risk Assessments and Health Hazard Evaluations for on-market products, coordinating with internal teams and leading effective analysis of the situation, problem definition, and impact.
• Analyze and trend complaint and failure-mode data, identify mitigations for threshold risks, and prepare and present findings to internal stakeholders where applicable.
• Lead cross-functional implementation of design or process changes, including drawing, fixture, or tooling updates, testing, and change-control documentation as applicable.
• Develop or improve testing methods used in complaint investigations and root cause activities.
• Train and mentor the complaint intake team to improve technical product knowledge and complaint evaluation quality; provide expertise on complex investigations.
• Assess product changes for impact to design and risk management and determine information required to support implementation.
• Provide post-market feedback from complaint trending and other forums to Operations, Engineering, and R&D to improve devices in the field and in development.
• Lead field investigations at customer sites with field-based teams, including sales and service, and urgently identify and resolve field quality issues while upholding the Hologic brand image and values.
• Present product quality metrics to leadership, explain root causes, and recommend actions or resolutions.
• Participate in internal and external audits as a product subject matter expert, including facility and supplier audits and Notified Body and FDA inspections.
• Review team inputs for monthly Quality Investigation Review boards and prepare and present material where applicable.

Benefits

• Comprehensive training upon joining and continued development and training throughout the career.
• Annualized base salary range of $119,300–$186,600; bonus eligible.

What This Job Offers

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