Senior Quality Engineer

Job Description

Job Description

Salary:

Luna Health created Sleep-Only Automation automated insulin delivery that works while you sleep and disappears when you wake. We're a venture-backed medical device startup that makes the worlds smallest insulin patch pump, solving the biggest problem in all of diabetes - nighttime glucose control for Type 1 diabetes and Type 2 diabetes insulin users who manage their days well and have made a considered choice to stay on pens. They don't need saving. They need protection while they sleep.

Our founders have lived this problem as people with diabetes and as parents of children with diabetes and built some of the most recognized products in the space. Now we are building the answer to a question the industry left unanswered: what do pen users need at night that no one has built yet. Sleep-Only Automation is it. Nights Protected. Days Yours.

The Role

We are hiring a Senior Quality Engineer to coordinate, document, and continuously improve Lunas Quality Management System (QMS) and to ensure commitments tied to regulatory and quality requirements are met. You will provide hands-on quality systems leadership across design controls, change control, CAPA, complaints, nonconformances, training, suppliers, and internal audits.

This is an in-office role in San Diego and will report to the Vice President, RA/QA/CA.

Responsibilities

Quality system and continuous improvement

• 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.
• Monitor company-wide quality objectives and ensure follow-through across functions.
  

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.

Change control and cross-functional quality partnership

• Represent Quality within the change control system. Review and approve changes as appropriate, ensuring impacts to risk, validation, labeling, suppliers, and regulatory commitments are evaluated.
• Support and improve training processes, including identifying changes to curricula and standards that affect QMS requirements.

CAPA, nonconformances, complaints, and supplier quality

• Lead and/or support CAPA activities, including problem definition, root cause analysis, effectiveness checks, and documentation quality.
• Support nonconforming material reports (NMR) and complaint handling processes, ensuring timely investigation and appropriate escalation.
• Support supplier assessment activities, including qualification, monitoring, and issue resolution in collaboration with operations and procurement.
• Define and support incoming inspection processes, calibration, and preventative maintenance activities.

Audits and inspection readiness

• Lead and manage the internal audit program, including audit planning, execution, reporting, and follow-up actions.
• Support external audits and inspections by ensuring audit readiness and objective evidence availability.

What you bring

• Bachelors degree in a technical discipline or equivalent practical experience.
• 45 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.

Nice to have

• Experience supporting design controls for software-enabled or connected medical devices.
• 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

What to expect

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. Finally, we will invite you on-site to discuss your experience and meet the team.

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.

Equal opportunity employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

Physical demands

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Sit for extended periods of time at a keyboard and mouse
• Lift and move up to 25 lbs
• Work in a second-story office up a flight of stairs
• Hearing and speaking will be required regularly
• Specific vision abilities include close and distance vision, depth perception, peripheral vision, and the ability to adjust focus

To all staffing and recruiting agencies

This posting is only for individuals seeking a job at Luna Health. Only authorized staffing and recruiting agencies may use this site or submit profiles, applications, or resumes on specific requisitions. Luna Health does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to Luna Health. Luna Health is not responsible for any fees related to unsolicited resumes or applications.