Location
Marlborough
Job Type
Full-time
Posted
July 08, 2026
Job Description
Quality Engineer 2
United States
Marlborough, MA, United States
Are you passionate about ensuring the highest quality standards for life-saving medical devices? At Hologic, we are seeking a **Quality Engineer II** to drive compliance, risk management, and continuous improvement across our product lifecycle.
In this role, you’ll collaborate with cross-functional teams to lead investigations, implement corrective actions, and support design transfers while leveraging your expertise in regulatory compliance and quality systems. If you’re a proactive problem-solver with a strong commitment to operational excellence and customer satisfaction, this is your opportunity to make a meaningful impact on healthcare innovation.
**Knowledge:**
+ In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product quality.
+ Strong understanding of risk management principles, including ISO 14971 an...
United States
Marlborough, MA, United States
Are you passionate about ensuring the highest quality standards for life-saving medical devices? At Hologic, we are seeking a **Quality Engineer II** to drive compliance, risk management, and continuous improvement across our product lifecycle.
In this role, you’ll collaborate with cross-functional teams to lead investigations, implement corrective actions, and support design transfers while leveraging your expertise in regulatory compliance and quality systems. If you’re a proactive problem-solver with a strong commitment to operational excellence and customer satisfaction, this is your opportunity to make a meaningful impact on healthcare innovation.
**Knowledge:**
+ In-depth knowledge of ISO 13485, FDA regulations, EU MDR/IVDR, and cGMP, ensuring regulatory compliance and product quality.
+ Strong understanding of risk management principles, including ISO 14971 an...