Senior Supplier Quality Engineer – Medical Devices

Modular Medical Inc; San Diego (CA); On-site; USD 110,000 - 180,000; Full time

Job summary

Modular Medical Inc in San Diego, CA, is seeking a Sr Supplier Quality Engineer to lead supplier quality activities and ensure compliance with FDA regulations, ISO 13485, and related standards. The role supports quality across materials, suppliers, and processes in a fast-paced medical device environment.

You will qualify suppliers via capability assessments and audits, manage SCARs, track quality metrics, and drive supplier development programs.

Qualifications

• BS degree in engineering, data science, technical or scientific discipline.
• Minimum5-8 years' experience in the FDA regulated environment, preferably associated with medical devices.
• Experience with supplier quality and quality systems compliance.
• Familiarity with FDA/ISO and IEC standards and regulations.
• Excellent verbal and written analytical/problem-solving, communication, negotiation, interpersonal and presentation skills.
• Advanced personal computing skills, including report writing and MS Office applications.

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 nonconformances and verify corrective action effectiveness
• Track and analyze supplier quality metrics and development of supplier scorecards
• Support supplier development programs and create improvement roadmaps with technical coaching
• Manage supplier containment during active nonconformances and coordinate with receiving inspection
• Assist in investigations and notifications related to nonconformances and changes
• Maintain positive relationships with vendors and support internal/external audits

Skills

Analytical thinking

Communication skills

Problem-solving

Interpersonal skills

Presentation skills

Education

Bachelor's degree in engineering, data science, technical or scientific discipline

Tools

MS Office

Quality management software

Job description

Modular Medical Inc in San Diego, CA, is seeking a Sr Supplier Quality Engineer to lead supplier quality activities and ensure compliance with FDA regulations, ISO 13485, and related standards. The role supports quality across materials, suppliers, and processes in a fast-paced medical device environment.

You will qualify suppliers via capability assessments and audits, manage SCARs, track quality metrics, and drive supplier development programs.