Senior Quality Engineer

Overview

At Lumicell, we’ll give you the opportunity to harness all that’s within you by working in a mission driven start-up environment with high-performing employees, tackling some of the most important challenges in cancer surgery. We are working to revolutionize the way cancer surgery is performed today, starting with breast cancer. Women in the US have a 1 in 8 lifetime risk of being diagnosed with breast cancer.

Every two minutes, a person is diagnosed. Our founder, David Lee lost his wife to breast cancer due to cancer being left behind during surgery. You will be a part of something groundbreaking as we transition from clinical development to our commercial launch.

• 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.

• 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
• 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

• 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).

• This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.
• This is a Hybrid position, and the ability to be on-site 3 days a week is required.

• Approximately 10% travel, primarily to support contract manufacturing partners or quality-related activities.

Lumicell is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Lumicell is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Lumicell will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.