Senior Medical Device Quality Engineer — Post-Market CAPA

Hologic, Inc.; Marlborough (MA); On-site; USD 98,000 - 135,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA is seeking a Sr. Product Quality Engineer to provide engineering support for on-market medical devices.

You will lead complaint investigations, perform root cause analyses, and implement CAPA to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements and risk management to enhance patient safety and customer satisfaction.

Qualifications

• Bachelor’s degree in engineering is required.
• 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.
• Familiarity with audits, including Notified Bodies and FDA inspections.

Responsibilities

• Lead complaint investigations and CAPA activities to resolve quality issues.
• Perform root cause analyses and risk assessments to prevent recurrence.
• Collaborate with Operations, R&D, and Engineering to drive product and process improvements.
• Mentor junior engineers and ensure compliance with regulatory standards.

Skills

Lead investigations

CAPA activities

Data analysis & trending

Risk management

Cross-functional collaboration

Communication & presentation

Education

Bachelor's degree in engineering

Tools

QMS familiarity

Job description

Hologic, Inc. in Marlborough, MA is seeking a Sr. Product Quality Engineer to provide engineering support for on-market medical devices.

You will lead complaint investigations, perform root cause analyses, and implement CAPA to improve product quality and compliance. Collaborating with cross-functional teams, you’ll drive process improvements and risk management to enhance patient safety and customer satisfaction.