Principal Post Market Quality Engineer

Hologic; Town of Newark (WI); Vor Ort; USD 138.000 - 230.000; Vollzeit

Zusammenfassung

Hologic is seeking a Principal Post Market Quality Engineer to act as the senior technical authority for PMQA, guiding post-market processes across Breast & Skeletal Health Solutions to ensure patient safety and regulatory compliance. The role involves risk-based decisions, data analysis, and cross-functional leadership to continuously improve the quality system.

The candidate will lead investigations, health risk assessments, and post-market data trending, while coordinating with design,

Qualifikationen

• Experience in medical device PMQA and post-market processes.
• Ability to make risk-based decisions under regulatory scrutiny.
• Experience supporting FDA inspections and CAPAs is preferred.

Aufgaben

• Serve as senior technical authority across PMQA processes.
• Lead investigations, trend data, and risk assessments.
• Develop and govern procedures, templates, and documentation.
• Coach engineers and process leads; collaborate with cross-functional teams.
• Represent PMQA during inspections and regulatory activities.

Kenntnisse

Technical leadership

Post Market QA

Regulatory knowledge

Data analysis

Risk assessment

Investigation leadership

Cross-functional collaboration

Training/coaching

Ausbildung

Bachelor’s Degree in Engineering

Advanced degree preferred

Tools

Salesforce-based complaint systems

Agile / electronic QMS

Design of experiments

Reliability analysis

Jobbeschreibung

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.

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, elevate, 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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

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.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.