Senior Post-Market Quality Engineer & Regulatory Lead

Hologic, Inc.; Marlborough (MA); On-site; USD 138,000 - 230,000; Full time

Job summary

Hologic, Inc. is seeking a Principal Post Market Quality Engineer to serve as the senior technical authority for Post Market Quality Assurance across Breast & Skeletal Health Solutions.

You will lead risk-based post-market processes to ensure patient safety, regulatory compliance, and continuous quality improvement across product lines. The role requires deep knowledge of post-market QA, regulatory requirements (FDA, ISO 13485, EU MDR), and experience guiding cross-functional teams through

Qualifications

• Bachelors Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical preferred.
• Advanced degree preferred.
• Masters degree or PhD with relevant experience preferred.
• Minimum 8 years of direct Post Market experience in medical device quality.
• Hands-on depth in at least two PMQA areas: complaint handling/investigation, medical device reporting, health risk assessment, data analysis/trending.
• Experience supporting FDA inspections and regulatory interactions is highly desirable.

Responsibilities

• Act as senior technical authority for PMQA processes and provide strategic direction.
• Lead gap assessments, remediation activities, and verification of effectiveness.
• Develop and defend risk-based technical decisions under regulatory scrutiny.
• Guide cross-functional teams without direct authority to improve PMQA systems.
• Enhance post-market data analysis, trending, and signal detection methods.
• Represent PMQA during inspections and audits; prepare responses and corrective actions.

Skills

PMQA expert

Procedures design

Risk-based decisions

Cross-functional leadership

Data analysis

Inspection readiness

Mentoring

AI in PMQA

Regulatory communications

Process improvement

Education

Bachelors Degree in Engineering

Masters Degree (preferred)

PhD (preferred)

Job description

Hologic, Inc. is seeking a Principal Post Market Quality Engineer to serve as the senior technical authority for Post Market Quality Assurance across Breast & Skeletal Health Solutions.

You will lead risk-based post-market processes to ensure patient safety, regulatory compliance, and continuous quality improvement across product lines. The role requires deep knowledge of post-market QA, regulatory requirements (FDA, ISO 13485, EU MDR), and experience guiding cross-functional teams through