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Senior Quality Engineer

Job description

The Role: We are hiring a Senior Quality Engineer to coordinate, document, and continuously improve 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:
  • 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.
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.