Senior Supplier Quality Engineer — Audit & Compliance

Socket.dev; San Diego (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Modular Medical is seeking a Sr Supplier Quality Engineer to join the Quality team in San Diego. You will qualify new suppliers, conduct on-site audits, manage SCARs, and drive supplier quality metrics to support FDA-regulated medical device manufacturing.

The role requires strong communication, problem-solving, and collaboration with receiving, manufacturing, and suppliers; you will ensure compliance with FDA, ISO 13485, and related standards, while promoting continuous improvement across the

Qualifications

• BS degree in engineering or related field; equivalent combination of education and experience.
• 5–8 years' experience in a FDA-regulated environment, preferably medical devices.
• Experience with supplier quality, quality systems and standards compliance.
• Familiarity with FDA/ISO/IEC standards and regulations.
• Excellent verbal and written analytical/problem-solving, communication, negotiation and presentation skills.

Responsibilities

• Qualify new suppliers through capability assessments, quality system audits, and initial sample approval processes.
• Conduct on-site supplier quality audits as required.
• Issue and manage supplier corrective action requests (SCARs) for incoming material nonconformances: define problem requirements, review root cause submissions, and verify corrective action effectiveness.
• Track and analyze supplier quality metrics, assist in development of supplier scorecards.
• Support critical supplier development programs: identify capability gaps, create improvement roadmaps, and provide technical coaching.
• Manage supplier containment activities during active quality nonconformances - requiring 100% inspection, sorting operations, or temporary supply from alternate sources.
• Coordinate with receiving inspection, quality engineering, and production on the disposition of nonconforming incoming material.
• Assist in nonconformance and complaint investigations, including notification to supplier of problems and batch record reviews.
• Manage and support the supplier notification process for changes, both supplier and company initiated changes.
• Maintain a positive working relationship with vendors.
• Support both internal & external audits, including front/back room support and audit responses.
• Complies with FDA regulations, other regulatory requirements, company policies, procedures, processes, and task assignments.
• Exercise good judgment in planning and organizing work; monitors performance and reports status.
• Maintain regular and predictable attendance.

Skills

Supplier quality

Quality systems

Regulatory compliance

Analytical thinking

Communication skills

Team collaboration

Education

BS degree in engineering/data science/technical or scientific discipline

Tools

MS Office

Statistical methods (SPC/DOE)

Job description

Modular Medical is seeking a Sr Supplier Quality Engineer to join the Quality team in San Diego. You will qualify new suppliers, conduct on-site audits, manage SCARs, and drive supplier quality metrics to support FDA-regulated medical device manufacturing.

The role requires strong communication, problem-solving, and collaboration with receiving, manufacturing, and suppliers; you will ensure compliance with FDA, ISO 13485, and related standards, while promoting continuous improvement across the