luna
Senior Quality Engineer
San Diego, California · Senior
Sponsorship not specifiedDetected 14 hours ago
AuditingFDA RegulatoryMedical DevicesLeadershipCollaborationInternal Audit
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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- This is an in-office role in San Diego and will report to the Vice President, RA/QA/CA.
Responsibilities
- Coordinate and maintain the QMS processes and documentation to ensure they are complete, current, and usable by cross-functional teams.
- Drive continuous improvement initiatives that strengthen compliance, effectiveness, and scalability of the QMS.
- Design controls and product development support
- Lead the design control program to ensure the design control process is complete, compliant, and well-documented.
- Partner with R&D, clinical, and operations to ensure quality requirements are met in an efficient, compliant, and scalable manner.
- Ensure appropriate risk management, traceability, and documentation practices are followed for design changes and design outputs.
- Establish and maintain production traceability standards that are right-sized with planned scalability.
- Support and improve training processes, including identifying changes to curricula and standards that affect QMS requirements.
- Lead and/or support CAPA activities, including problem definition, root cause analysis, effectiveness checks, and documentation quality.
- Now we are building the answer to a question the industry left unanswered:
Requirements
- Bachelor's degree in a technical discipline or equivalent practical experience.
- 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.
- Hearing and speaking will be required regularly
- 4-5 years of experience in a quality role within a medical device manufacturing environment.
- 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.
Nice to have
- Experience with supplier quality in early-stage, rapidly scaling manufacturing environments.
- Experience supporting FDA inspections and responding to audit findings.
- Experience within the diabetes clinical space
- MDR and CE marking
- The first step is to apply for this job on our website.
- Next, we will schedule a virtual interview with the hiring manager to introduce you to the company and the role.
- Equal opportunity employer
- Physical demands
Benefits
- Luna Health created Sleep-Only Automation - automated insulin delivery that works while you sleep and disappears when you wake.
- Specific vision abilities include close and distance vision, depth perception, peripheral vision, and the ability to adjust focus
Company info
- We are in a hurry to find the right person, not in a hurry to hire, so we will take time getting to know you and making sure that you will be an excellent fit for the work that we are doing.
This listing is sourced directly from luna's careers page and normalized into a canonical job model.