Senior Medical Device Quality Engineer - CAPA & Compliance

DIRECT SALES, US; Marlboro (MA); On-site; USD 98,000 - 135,000; Full time

Job summary

Hologic, a global leader in womens health, seeks a Sr. Product Quality Engineer to ensure the reliability of life-saving medical devices. You will lead investigations, drive CAPA, and mentor junior engineers in a regulated environment.

Based in Marlborough, MA, this role collaborates with Operations, R&D, and Engineering to improve processes, manage risk, and ensure compliance with FDA QSR and ISO 13485. The position offers competitive salary with bonus eligibility and growth opportunities.

Qualifications

• 5+ years in quality engineering or R&D in FDA-regulated industry.
• Hands-on in complaint investigations and CAPA.
• Experience with audits including FDA inspections.
• Bachelor’s degree in engineering required.

Responsibilities

• Lead complaint investigations and CAPA activities.
• Perform root cause analyses and risk assessment.
• Collaborate with Operations, R&D, and Engineering to improve quality.
• Ensure compliance with FDA, ISO 13485, GDP.

Skills

Complaint Investigations

Root Cause Analysis

CAPA Management

Data Analysis

Regulatory Compliance

Cross-functional Collaboration

Process Improvement

Education

Bachelor’s degree in Engineering

Job description

Hologic, a global leader in womens health, seeks a Sr. Product Quality Engineer to ensure the reliability of life-saving medical devices. You will lead investigations, drive CAPA, and mentor junior engineers in a regulated environment.

Based in Marlborough, MA, this role collaborates with Operations, R&D, and Engineering to improve processes, manage risk, and ensure compliance with FDA QSR and ISO 13485. The position offers competitive salary with bonus eligibility and growth opportunities.