Lumicell

Senior Quality Engineer

Lumicell

full-time

Posted on:

Location Type: Hybrid

Location: Newton • Massachusetts • United States

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Job Level

Senior

About the role

  • Own and maintain Complaint Handling, CAPA, and Document Control processes, ensuring compliance with applicable FDA regulations and ISO standards
  • Lead and support post-market quality activities, including complaint intake, investigation, trending, and signal detection
  • Serve as a key Quality partner supporting pharmacovigilance and clinical activities
  • Drive effective CAPA management, including root cause analysis, risk-based scoping, effectiveness checks
  • Support audit and inspection readiness, including internal audits, external audits, and FDA inspections
  • Collaborate cross-functionally with Clinical Affairs, Product Development, Manufacturing, Clinical Engineering, and the Commercial teams.

Requirements

  • Bachelor’s degree in Engineering, Chemistry, Chemical Engineering, or a related technical discipline
  • 7-10+ years of experience in quality roles within the medical device, pharmaceutical, or combination-product industry
  • Comprehensive knowledge of FDA and international regulatory standards applicable to medical devices and pharmaceuticals, including QMSR, 21 CFR Parts 4, 820, 803, 806, and 210/211, and relevant ISO/ICH standards
  • Demonstrated experience with Complaint handling and complaint trending
  • CAPA management and root cause analysis
  • Supporting post-market surveillance and regulatory reporting
  • Adept with electronic QMS maintenance and continuous improvement (Arena preferred)
  • Excellent problem-solving, organizational, and communication skills.
  • Ability to operate independently while collaborating effectively in a fast-paced environment.
Benefits
  • Lumicell is committed to a Diverse and Inclusive workplace.
  • Opportunity to work in a mission-driven start-up environment with high-performing employees.
  • Training and professional development opportunities.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Complaint HandlingCAPA managementroot cause analysisrisk-based scopingeffectiveness checkspost-market surveillanceregulatory reportingelectronic QMS maintenancecontinuous improvementquality management systems
Soft Skills
problem-solvingorganizational skillscommunication skillscollaborationindependence