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.

Senior/Principal Quality Engineer

Lumicell is hiring a Senior/Principal Quality Engineer to be responsible for quality assurance, regulatory compliance, and operational excellence of drug-device combination products from clinical through commercial phase.

What you will do:

• Lead quality operations, including but not limited to design controls, document control, CAPAs, NCMRs, deviations, software quality, process validation, etc.
• Act as a subject matter expert in design quality and risk management to support product improvements
• Lead supplier quality management for drug and device supply chain, including evaluation/selection and supplier monitoring of suppliers, including contract manufacturers and other key service suppliers.
• Conduct internal/supplier audits and support external audits.
• Contribute to post-market surveillance activities, including complaint management, trending complaint data, and evaluation for corrections/recalls.
• Create routine quality metrics to monitor performance and support management review and ensure regulatory compliance.
• Support continuous improvement of quality management system (QMS) for drug-device combination product in compliance with applicable FDA regulations (21 CFR Parts 820, 210/211) and relevant ISO standards (ISO 13485, ISO 14971, etc.) to support a commercial and clinical organization.
• Collaborate closely with Product Development (Drug and Device), Manufacturing Engineering, Field Service Engineering, Clinical/Medical Affairs, and Marketing/Sales Operations to integrate quality considerations throughout product life cycle.
• Support regulatory submissions for product changes, annual reports, etc.

What you will need:

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Chemical Engineering, or a related technical discipline; Master’s degree preferred.
• 5-10+ years of experience in quality roles within the medical device and/or pharmaceutical industry (Class III / novel / combination products preferred).
• Comprehensive knowledge of FDA and international regulatory standards applicable to medical devices and pharmaceuticals, including 21 CFR Parts 820, 803, 806, and 210/211, and relevant ISO/ICH standards (e.g., ISO 13485, IEC 60601, IEC 62304, etc).
• Proven track record in managing supplier quality across a complex supply chain (drug and device).
• Previous experience with complaint management.
• Adept with electronic QMS maintenance and continuous improvement (Arena preferred).
• Excellent problem-solving, organizational, and communication skills.

An outstanding candidate will also possess the below experience:

• Lead auditor certified and/or CQE, Six Sigma training/certified.

• Experience with current FDA software and cybersecurity regulations, standards, and guidance.

• Previous experience in a startup environment.
• Previous experience with combination products post-market surveillance and reportability, including drug pharmacovigilance/AEs, device complaint management/MDRs, and annual reporting requirements under PMA/NDA.

Travel Requirements
Travel may be required for about 10% of the time to support key contract manufacturing operations.

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.