Medical Device Quality Engineer II — Post-Market CAPA

Hologic, Inc.; Marlborough (MA); On-site; USD 78,000 - 122,000; Full time

Job summary

Hologic, Inc. is seeking a Product Quality Engineer 2 to provide quality engineering support for on-market medical devices.

You will lead complaint investigations, perform risk assessments, conduct root cause analyses, and drive cross-functional corrective actions to ensure product quality, regulatory compliance, and continuous improvement. This role requires 2–5 years of relevant engineering experience in FDA-regulated environments.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or Biomechanical preferred).
• 2–5 years of relevant engineering experience in FDA-regulated environments.
• Experience with post-market activities: complaint investigations, CAPA evaluation, and regulated product changes.
• Strong communication of findings, recommendations, and scope to stakeholders and leadership.

Responsibilities

• Lead complaint evaluations and investigations for on-market medical devices.
• Perform risk assessments and root cause analysis to drive corrective actions.
• Coordinate cross-functional teams to implement improvements and support CAPA decisions.
• Communicate investigation outcomes and recommended changes to leadership and stakeholders.
• Support change control activities and health risk assessments as needed.

Skills

Complaint investigations

Root cause analysis

Risk assessments

CAPA evaluation

Cross-functional leadership

Change control

Education

Bachelor’s degree in Engineering

Job description

Hologic, Inc. is seeking a Product Quality Engineer 2 to provide quality engineering support for on-market medical devices.

You will lead complaint investigations, perform risk assessments, conduct root cause analyses, and drive cross-functional corrective actions to ensure product quality, regulatory compliance, and continuous improvement. This role requires 2–5 years of relevant engineering experience in FDA-regulated environments.