Job DescriptionThe 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.
Skills- 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.
Experience- Bachelor's Degree in Engineering required; Mechanical, Electrical, Biomedical, or Biomechanical Engineering preferred.
- Advanced degree 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
- 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.
The annualized base salary range for this role is $138,000 - $230,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.
Agency and Third-Party Recruiter NoticeAgencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
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