Senior Supplier Quality Engineer — Medical Devices & Compliance

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

Job summary

Modular Medical is seeking a Sr Supplier Quality Engineer in San Diego to lead supplier quality initiatives and ensure compliance with FDA and ISO regulations. You will collaborate across functions to drive quality improvements, audits, and containment activities for incoming materials.

The role emphasizes strong communication, problem-solving, and data-driven decision making in a fast-paced medical device environment.

Qualifications

• BS degree in engineering or related scientific discipline; and/or equivalent education/experience.
• Minimum 5–8 years' experience in FDA-regulated environment, preferably medical devices.
• Ability to work with minimal supervision and apply judgment to meet goals.
• Experience with supplier quality and quality systems/regulatory compliance.
• Familiarity with FDA/ISO/IEC standards and regulations.
• Strong analytical, communication, negotiation, and presentation skills.
• Proficiency with MS Office and data reporting tools.

Responsibilities

• Qualify new suppliers via capability assessments, audits, and sample approvals.
• Conduct on-site supplier quality audits as required.
• Issue and manage supplier corrective action requests (SCARs) and verify effectiveness.
• Track supplier quality metrics and assist in developing supplier scorecards.
• Support supplier development programs and provide technical coaching.
• Manage containment activities during quality nonconformances with 100% inspection when needed.
• Coordinate with receiving, quality engineering, and production on dispositions of nonconforming material.
• Assist in investigations and notify suppliers of problems and batch reviews.

Skills

Supplier quality

Quality systems

FDA/ISO knowledge

Communication skills

MS Office

Team collaboration

Problem solving

Education

BS in engineering

FDA regulated experience

Tools

MS Office

Job description

Modular Medical is seeking a Sr Supplier Quality Engineer in San Diego to lead supplier quality initiatives and ensure compliance with FDA and ISO regulations. You will collaborate across functions to drive quality improvements, audits, and containment activities for incoming materials.

The role emphasizes strong communication, problem-solving, and data-driven decision making in a fast-paced medical device environment.