Principal Post Market Quality Engineer

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. 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. Preferred knowledge of Salesforce-based complaint systems, Agile or other electronic QMS systems, test method validation, design of experiments, and reliability analysis.

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. Preferred certifications include ASQ CQE, CRE, or CQA.

Behavior

Acts with complete autonomy and independent judgment on complex, high-risk, or unique assignments. Demonstrates technical leadership without direct supervisory responsibility. Operates with urgency to identify, escalate, and resolve quality issues. Influences without authority and builds credibility with senior leaders, process owners, regulators, and cross-functional partners. Thinks systemically, ensuring PMQA processes operate as an integrated, compliant, and sustainable system. Uses sound judgment when evaluating ambiguous data, intangible factors, and regulatory risk. Maintains consistency in methods, decision criteria, and documentation across processes, sites, and product lines. Models Hologic and BSHS quality values while protecting patient safety and the Hologic brand. Builds formal networks across functions to support quality objectives and organizational goals. Coaches others and builds organizational capability through mentoring and training.

Bachelor’s Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred. Advanced degree