Quality Engineer II, Medical Devices - CAPA & RCA

Hologic, Inc.; Newark (DE); On-site; USD 78,000 - 122,100; Full time

Benefits offered by this job

Comprehensive training

Continuous career development

Job summary

A leading medical technology company in Newark, Delaware is seeking a Product Quality Engineer 2 to support on-market medical devices. Your role will include leading investigations into complaints, performing root cause analyses, and driving process improvements to enhance product quality and compliance. Candidates should have a Bachelor's degree in Engineering and 2-5 years of relevant experience in quality engineering within an FDA-regulated environment. This position offers a competitive salary range of $78,000-$122,100 and bonus eligibility.

Qualifications

• 2-5 years of experience in quality engineering, preferably in FDA-regulated industry.
• Hands-on experience in complaint investigations and CAPA activities.

Responsibilities

• Provide engineering support for on-market medical devices.
• Lead complaint investigations and implement corrective actions.
• Drive process improvements and assess risks.

Skills

Lead complaint investigations

Data analysis and trending

Effective communication

Assessment of product changes

Developing testing methods

Collaboration with cross-functional teams

Familiarity with verification and validation

Education

Bachelor's degree in Engineering

Job description

A leading medical technology company in Newark, Delaware is seeking a Product Quality Engineer 2 to support on-market medical devices. Your role will include leading investigations into complaints, performing root cause analyses, and driving process improvements to enhance product quality and compliance. Candidates should have a Bachelor's degree in Engineering and 2-5 years of relevant experience in quality engineering within an FDA-regulated environment. This position offers a competitive salary range of $78,000-$122,100 and bonus eligibility.