Hologic-posted 3 months ago
$145,500 - $242,400/Yr
Full-time • Senior
Newark, DE
Computer and Electronic Product Manufacturing

Are you a proven leader passionate about driving product improvements, enhancing post-market quality processes, and delivering impactful solutions? At Hologic, we are seeking a Senior Manager, Post-Market Quality & Product Improvement to lead post-market investigations, manage quality-related business processes, and implement product changes informed by customer feedback and data. In this key role, you'll oversee a team of Quality Design Engineers (QDEs), collaborate cross-functionally across the organization, and ensure our products remain safe, compliant, and aligned with customer needs. If you thrive on leadership, strategic project management, and delivering meaningful outcomes in a regulated environment, this opportunity is for you!

  • Lead post-market investigations and manage quality-related business processes.
  • Implement product changes informed by customer feedback and data.
  • Oversee a team of Quality Design Engineers (QDEs).
  • Collaborate cross-functionally across the organization.
  • Ensure products remain safe, compliant, and aligned with customer needs.
  • 10+ years of experience with a Bachelor's degree, 7+ years with a Master's degree, or 5+ years with a PhD in engineering or a scientific discipline.
  • Management experience in a medical device, pharmaceutical, or heavily regulated industry.
  • Comprehensive understanding of Post-Market quality processes, including complaint handling, root cause analysis, and regulatory reporting.
  • In-depth knowledge of regulatory requirements such as 21 CFR Part 820, Part 803, ISO 13485:2016, EU MDR, and Canadian MDR.
  • Expertise in design verification/validation, GMP, and Quality Systems Regulations.
  • Familiarity with risk management processes (e.g., ISO 14971), CAPA, and change control procedures.
  • Proficiency in CAD tools (e.g., SolidWorks), statistical analysis software (e.g., MiniTab), and metrics development.
  • PMP certification.
  • Lean Six Sigma Green or Black Belt certification.
  • Experience working with capital equipment in healthcare settings.
  • Comprehensive training upon joining and continued development throughout your career.
  • Annualized base salary range of $145,500-$242,400, bonus eligible.
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