Product Quality Engineer II CAPA & Compliance Leader

DIRECT SALES, US; Newark (DE); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic is seeking a Product Quality Engineer 2 to support on-market medical devices. You will lead complaint investigations, perform root cause analyses, and drive corrective and preventive actions to improve product quality and compliance.

Responsibilities include collaborating with Operations, R&D, and Engineering to mitigate risks, enhance patient safety, and ensure regulatory adherence. The role emphasizes data-driven decisions and effective communication with stakeholders.

Qualifications

• Bachelor's degree in Engineering required.
• 2–5 years of experience in quality engineering, product development, or R&D in FDA-regulated industry.
• Hands-on experience in complaint investigations, root cause analysis, and CAPA activities.
• Familiarity with audits, Notified Body and FDA inspections.

Responsibilities

• Lead complaint investigations and CAPA activities to resolve quality issues.
• Perform root cause analyses and implement corrective actions.
• Develop or improve testing methods for investigations and technical activities.
• Collaborate with cross-functional teams to drive product and process improvements.
• Assess design changes for risk management impact and regulatory compliance.

Skills

Complaint investigations

Root cause analysis

CAPA management

Data analysis

Risk assessment

Cross-functional collaboration

Communication skills

Regulatory compliance

Testing method development

Education

Bachelor's degree in Engineering

Job description

Hologic is seeking a Product Quality Engineer 2 to support on-market medical devices. You will lead complaint investigations, perform root cause analyses, and drive corrective and preventive actions to improve product quality and compliance.

Responsibilities include collaborating with Operations, R&D, and Engineering to mitigate risks, enhance patient safety, and ensure regulatory adherence. The role emphasizes data-driven decisions and effective communication with stakeholders.