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.

• 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.

• 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…