Design Quality Engineer

Quality Engineer / Senior Quality Engineer

Location : San Diego, CA (Hybrid)

We're seeking a hands-on and detail-oriented Quality Engineer to join our growing Quality Assurance and Regulatory Affairs team. The ideal candidate will have a strong engineering background with experience across the full product lifecycle—from design through manufacturing—within the medical device industry.

This individual will play a key role in shaping and strengthening our Quality Management System (QMS), with opportunities to lead validation, process improvement, and regulatory readiness initiatives.

Role & Responsibilities

• Partner with R&D to define product requirements and release criteria; support design reviews and ensure robust technical documentation.
• Lead risk management activities (FMEA / DFMEA / PFMEA) and maintain traceability throughout the design process.
• Author, maintain, and execute design verification and validation (V&V) protocols and reports; lead hands-on test method validations (TMVs) and formal V&V testing.
• Execute and document intended-use and computer system validations , ensuring systems meet regulatory and business needs.
• Drive QMS remediation and continuous improvement initiatives —identify procedural or documentation gaps proactively, develop and implement sustainable fixes, and ensure alignment with FDA QMSR and ISO 13485.
• Draft, revise, and maintain SOPs and quality procedures ; support internal audits, CAPA, and monitoring of quality metrics.
• Contribute to regulatory submissions (e.g., 510(k), Letters to File, labeling, technical documentation) and ensure compliance with global regulatory standards.
• Oversee supplier qualification , conduct supplier audits, and drive supplier corrective and preventive actions (SCARs).
• Develop inspection plans; support inventory control, equipment / tool calibration, and process validation (IQ / OQ / PQ) activities.
• Collaborate across Operations, Manufacturing, and Supply Chain to communicate risks, mitigations, and timelines effectively.
• Mentor junior team members and help foster a culture of continuous learning and improvement.

Requirements