Opportunity Description
Product Quality Engineer II
Newark, DE, United States
Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a **Product Quality Engineer 2** to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.
**Knowledge:**
+ Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), ...
Newark, DE, United States
Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a **Product Quality Engineer 2** to provide engineering support for on-market medical devices. In this role, you’ll lead complaint investigations, perform root cause analyses, and implement corrective and preventive actions to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements, assess risks, and deliver impactful solutions that enhance patient safety and customer satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply and make a difference in healthcare innovation.
**Knowledge:**
+ Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), ...
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