Supplier Quality Engineer, Medical Devices

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Quality Consulting Group, LLC seeks a motivated professional to strengthen supplier qualification and quality systems in Puerto Rico and the U.S. You will interface with R&D, sourcing, engineering, and operations to drive continuous improvement and regulatory compliance in a dynamic medical device environment.

Responsibilities include defining supplier quality programs, coordinating in-process inspections, and ensuring adherence to ISO 13485 and FDA QMSR standards.

Qualifications

• Bachelor’s degree in related area.
• 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
• Demonstrated experience in Medical Device Industry.
• Experience with Agile and TrackWise is a plus.
• Knowledge of ISO 13485 requirements.
• Knowledge of FDA QMSR.
• Knowledge of Geometric Tolerances.

Responsibilities

• Increase SQ activities for business growth and supplier base qualification, and yield improvements.
• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers per company standards; may administer a Certified Supplier Program in receiving inspection.
• Monitor parts from acquisition through manufacturing and resolve supplier-related problems.
• Assess suppliers’ internal functions and provide performance feedback.
• Collaborate with R&D, sourcing, engineering, operations, and quality to deliver quality parts and services.

Skills

Quality mindset

Agile

TrackWise

Geometric tolerances

FDA QMSR knowledge

Education

Bachelor’s degree in related area

Tools

TrackWise software

Job description

Quality Consulting Group, LLC seeks a motivated professional to strengthen supplier qualification and quality systems in Puerto Rico and the U.S. You will interface with R&D, sourcing, engineering, and operations to drive continuous improvement and regulatory compliance in a dynamic medical device environment.

Responsibilities include defining supplier quality programs, coordinating in-process inspections, and ensuring adherence to ISO 13485 and FDA QMSR standards.