Senior Quality Engineer, Medical Device QMS & Compliance

luna; San Diego (CA); On-site; USD 85,000 - 105,000; Full time

Job summary

Luna Health is hiring a Senior Quality Engineer to own and improve the Quality Management System, ensuring regulatory and quality commitments are met across design controls, CAPA, changes, and supplier quality. This in‑office role is based in San Diego and reports to the Vice President, RA/QA/CA.

The ideal candidate will drive cross‑functional quality initiatives, lead audits, and partner with R&D, clinical, and operations to maintain production traceability and risk management.

Qualifications

• Bachelor’s degree in a technical discipline or equivalent practical experience.
• 4–5 years of experience in a quality role within a medical device manufacturing environment.
• 3+ years of quality system auditing experience, including planning and executing audits.
• Demonstrated expertise in documented quality systems and strong comprehension of QMS concepts and process-based quality.
• Strong command of ISO quality systems and harmonized standards relevant to medical devices.
• Strong interpersonal skills. Able to influence across functions and communicate clearly at all levels.
• Practical, hands‑on execution style. Comfortable doing the work and driving others to closure.

Responsibilities

• Quality system and continuous improvement: Coordinate and maintain QMS processes and documentation for cross‑functional teams.
• Design controls and product development support: Lead design control program and ensure compliance with R&D, clinical, and operations.
• Change control and cross‑functional quality partnership: Represent Quality within change control and support training processes.
• CAPA, nonconformances, complaints, and supplier quality: Lead/Support CAPA, NMRs, complaint handling, supplier qualification and monitoring.
• Audits and inspection readiness: Lead internal audit program and support external audits and inspections.

Skills

Interpersonal skills

Hands-on execution

Process-based quality

Education

Bachelor’s degree in a technical discipline

Tools

QMS concepts

ISO quality systems

Job description

Luna Health is hiring a Senior Quality Engineer to own and improve the Quality Management System, ensuring regulatory and quality commitments are met across design controls, CAPA, changes, and supplier quality. This in‑office role is based in San Diego and reports to the Vice President, RA/QA/CA.

The ideal candidate will drive cross‑functional quality initiatives, lead audits, and partner with R&D, clinical, and operations to maintain production traceability and risk management.