Principal Post Market Quality Engineer

Hologic • Newark, DE

3d • $138,000 - $230,000

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.

Requirements

• 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.
• 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.
• Experience providing technical leadership across product lines, sites, and cross-functional teams.

Nice To Haves

• 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.
• Advanced degree preferred.
• 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.

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
• bonus eligible

What This Job Offers

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