Principal Post Market Quality Engineer

Hologic • Newark, NJ

2d

About The Position

The Principal Post Market Quality Engineer serves as the senior technical authority for Post Market Quality Assurance, leading integrated, compliant, and risk-based post-market processes across Breast & Skeletal Health Solutions product lines to ensure patient safety, regulatory compliance, and continuous quality system improvement. This role requires a deep understanding of medical device regulations and quality system requirements, including 21 CFR Part 820 / QMSR, 21 CFR Part 803, 21 CFR Part 806, 21 CFR Parts 1000–1050, ISO 13485, ISO 14971, EU MDR vigilance requirements, and MDSAP. The engineer will also have a strong understanding of FDA, Notified Body, and MDSAP inspection expectations, risk management principles, and how Post Market processes interact with other quality system functions. Awareness of evolving global regulations and practices is also crucial.

Requirements

• Bachelor’s Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
• Required experience level: Bachelor’s degree with 10+ years of relevant experience, or Master’s degree with 8+ years of relevant experience, or PhD with 5+ years of relevant experience.
• Experience should be in medical device quality engineering or a related field.
• Minimum 8 years of direct Post Market experience.
• Hands-on depth required in at least two of the following areas, with working knowledge of all: Complaint handling and investigation, Medical device reporting, Health risk assessment, Data analysis and trending.
• Knowledge Expert understanding of Post Market Quality Assurance processes across complaint handling, complaint investigation, medical device reporting, reportability, health risk assessment, and post-market data analysis/trending.
• Deep knowledge of medical device regulations and quality system requirements, including: 21 CFR Part 820 / QMSR, 21 CFR Part 803, 21 CFR Part 806, 21 CFR Parts 1000–1050, ISO 13485, ISO 14971, EU MDR vigilance requirements, MDSAP.
• Strong understanding of FDA, Notified Body, and MDSAP inspection expectations.
• Knowledge of risk management, health risk assessment, Health Hazard Evaluation, patient impact assessment, and risk acceptability.
• Knowledge of how Post Market processes interact with design, manufacturing, CAPA, nonconformance, field actions, and overall quality system remediation.
• Understanding of statistical methods, trending, signal detection, and emerging-risk evaluation.
• Awareness of evolving global regulations, guidance, and industry practices.

Nice To Haves

• Advanced degree preferred.
• Preferred knowledge of Salesforce-based complaint systems, Agile or other electronic QMS systems, test method validation, design of experiments, and reliability analysis.
• Preferred certifications include ASQ CQE, CRE, or CQA.
• Strongly preferred experience supporting FDA inspections and responding to inspectional observations.
• Preferred experience with capital equipment, radiation-emitting products, and single-use or sterile devices.
• Experience leading or supporting quality system remediation and improvement programs.
• Experience providing technical leadership across product lines, sites, and cross-functional teams.

Responsibilities

• Serves as a senior technical authority and subject matter expert across PMQA processes.
• Designs, improves, and governs procedures, decision trees, forms, templates, and technical documentation.
• Makes and defends risk-based technical and process decisions under regulatory scrutiny.
• Leads gap assessments, remediation activities, process improvements, retrospective reviews, and verification of effectiveness.
• Provides technical direction to process leads and cross-functional teams without direct authority.
• Supports complex complaint investigations, root cause analysis, escalation decisions, reportability assessments, CAPA, nonconformance, and field action evaluations.
• Enhances post-market data analysis, trending, and signal detection methods.
• Evaluates potential use of artificial intelligence in Post Market processes, including benefit, risk, validation, and regulatory compliance considerations.
• Represents PMQA during inspections and audits, including readiness preparation, storyboards, observation responses, and corrective actions.
• Communicates effectively with executives, regulators, inspectors, technical teams, and cross-functional partners.
• Coaches, mentors, and trains engineers, specialists, and process leads.

Benefits

• Comprehensive training when you join
• Continued development and training throughout your career
• Annualized base salary range for this role is $138,000 - $230,000
• Bonus eligible

What This Job Offers

• Job Type: Full-time
• Career Level: Senior