Lumicell · 18 hours ago
Senior Quality Engineer
Newton, MA
Full-time
Hybrid
Senior Level
7+ years expLumicell is a mission-driven startup focused on revolutionizing cancer surgery, particularly for breast cancer. They are seeking a Senior Quality Engineer to manage quality systems and post-market operations for a drug-device combination product, ensuring compliance with FDA regulations and ISO standards while supporting clinical activities and product commercialization.
BiotechnologyHardwareHealth CareHealth DiagnosticsMedical
Responsibilities
Own and maintain Complaint Handling, CAPA, and Document Control processes, ensuring compliance with applicable FDA regulations and ISO standards from clinical development through commercial launch
Lead and support post-market quality activities, including complaint intake, investigation, trending, and signal detection, assess MDR reportability, field actions, and corrective actions as needed
Serve as a key Quality partner supporting pharmacovigilance and clinical activities, including adverse event assessment, safety documentation, and coordination with internal stakeholders and external safety vendors to ensure compliant safety reporting for the combination product
Drive effective CAPA management, including root cause analysis, risk-based scoping, effectiveness checks, and cross-functional execution, while monitoring quality metrics and contributing to Management Review and continuous improvement initiatives
Support audit and inspection readiness, including internal audits, external audits, and FDA inspections, and contribute to audit responses, remediation activities, and maintenance of a sustainable, inspection-ready Quality System
Collaborate cross-functionally with Clinical Affairs, Product Development, Manufacturing, Clinical Engineering, and the Commercial teams to integrate quality and compliance considerations throughout the product lifecycle
Qualification
Required
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 (e.g., ISO 13485, IEC 60601, IEC 62304, etc)
Demonstrated experience with Complaint handling and complaint trending
Demonstrated experience with CAPA management and root cause analysis
Demonstrated experience with 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
Preferred
Experience supporting pharmacovigilance for combination products, including adverse events and safety reporting
Prior exposure to Class III, novel, or PMA-regulated products
Lead Auditor certification, CQE, or Six Sigma training
Startup or early-commercial-stage company experience
Familiarity with FDA inspections involving combination products (device + drug)
Company
Lumicell
Lumicell is a biotechnology company that develops and markets image-guided cancer surgery solutions.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$278.62MKey Investors
National Science Foundation
2025-05-06Undisclosed· $198.13M
2024-07-24Series Unknown· $2.73M
2024-07-24Debt Financing
Leadership Team
Brian Schlossberg
Vice President, New Business Strategy and Innovation
Brent Palmisano
Chief Commercial Officer (CCO)
Recent News
2026-01-09
Company data provided by crunchbase