Quality Engineer 3

Hologic, Inc.; Marlborough (MA); On-site; USD 85,100 - 133,300; Full time

Job summary

Hologic, Inc. in Marlborough, MA, is seeking a senior Quality Engineer to support the medical device lifecycle. The role leads cross-functional quality initiatives, validates processes, and drives investigations, risk management, and continuous improvement with minimal supervision.

The ideal candidate has 7+ years in medical devices, CQE or Six Sigma certifications, and strong knowledge of ISO 13485, FDA, and cGMP. Salary ranges and bonus eligibility reflect market demand and location.

Qualifications

• Bachelor’s degree in a related discipline or equivalent.
• 7+ years of experience as a quality professional in the medical device industry.
• ASQ Certified Quality Engineer (CQE) and/or Six Sigma certification preferred.

Responsibilities

• Lead Nonconforming Event (NCE) investigations, including risk assessment and root cause analysis.
• Compile, analyze, and interpret quality metrics and drive corrective actions.
• Develop and update PFMEAs throughout the product lifecycle and ensure ISO 14971 compliance.
• Lead CAPA activities and drive effective corrective actions.
• Support New Product Introduction and product transfers with design transfers to production.
• Author, review, and approve technical reports and validation documentation.
• Develop, review, and approve quality plans to ensure compliance.
• Contribute to Operational Excellence using lean methods and statistics.
• Mentor junior quality engineers and promote continuous improvement.

Skills

ISO 13485 & FDA regs

PFMEA & risk management

Six Sigma / DOE / SPC

Root cause analysis

Technical writing

Cross-functional leadership

Education

Bachelor's degree in related discipline

Tools

Quality Management Systems

Enterprise systems

Job description

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 improvement.
• Proven experience in root cause investigations, NCE management, and CAPA.
• Strong technical writing and communication skills for validations and compliance documentation.
• Experience with Quality Management Systems, enterprise systems, and quality metrics.
• Leadership and mentorship capabilities; effective cross-functional collaboration and partnership-building; understanding of lean manufacturing principles.

The annualized base salary range for this role is $85,100 to $133,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Hologic’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.