Quality Engineer 3

Hologic · United States

Join Hologic, a global leader in women's health, dedicated to developing innovative medical technologies that help detect, diagnose, and treat disease with greater accuracy and confidence. Headquartered in Marlborough, MA, Hologic's solutions impact millions of women worldwide across breast health, gynecologic health, and diagnostics. As part of our team, you'll contribute to products that improve patient outcomes and advance the standard of care, helping fulfill our mission of enabling healthier lives everywhere. Position Summary The Quality Engineer 3 provides advanced quality engineering support across the medical device manufacturing lifecycle. This role leads cross-functional quality initiatives, supports design transfer and production, and ensures processes comply with applicable regulations, standards, and Hologic’s Quality Management System. Operating with minimal supervision, the position drives investigations, validations, risk management, and continuous improvement while mentoring junior engineers. Key Responsibilities * Lead Nonconforming Event (NCE) investigations, including risk assessment, root cause analysis, impact evaluation, and timely disposition, ensuring compliance with regulatory and quality system requirements. * Compile, analyze, and interpret quality metrics (e.g., NCEs, compliance metrics, management reviews, product quality indicators), identify key process indicators, and drive corrective actions to address unfavorable trends. * Develop, maintain, and update PFMEAs throughout the product lifecycle; ensure adherence to ISO 14971 and other risk management standards during design transfer and production. * Lead CAPA activities, driving effective root cause analysis and sustainable corrective and preventive actions. * Support New Product Introduction (NPI) and product transfers by facilitating design transfers to production and between sites while maintaining compliance. * Author, review, and approve technical reports and documentation for test method validations and process validations (IQ, OQ, PQ). * Develop, review, and approve quality plans to ensure product and process compliance. * Contribute to Operational Excellence and continuous improvement initiatives, applying lean principles and statistical tools (Six Sigma, SPC, DOE) to improve process capability and performance. * Mentor and guide junior quality engineers, promoting ownership, collaboration, customer focus, and a culture of continuous improvement. Compliance, Integrity, and Culture * Ensure adherence to company policies, safety regulations, PPE requirements, SOPs, QMSR, ISO standards, and Good Documentation Practices. * Demonstrate integrity, respect, collaboration, and innovation while contributing to a positive, inclusive, and team-oriented work environment. * Participate in training, workshops, and continuous improvement activities; promote sustainable practices (waste reduction, recycling, energy conservation). Qualifications * Bachelor’s degree in related discipline, or equivalent combination of education and experience. * 7+ years of experience as a Quality Professional in the medical device industry, or equivalent. * ASQ Certified Quality Engineer (CQE) and/or Six Sigma certification preferred. Key Skills

• Strong knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP.
• Expertise in risk management (ISO 14971, PFMEA) and design transfer.
• Proficiency in Six Sigma, SPC, DOE, and data analysis for process

• Proven experience in root cause investigations, NCE management, and CAPA.
• Strong technical writing and communication skills for validations and

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