Senior Supplier Quality Engineer – Medical Devices

Quality Consulting Group, LLC; Puerto Rico; Hybrid; USD 85,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC seeks a skilled professional to manage supplier quality in a world-class manufacturing context in Puerto Rico and the USA. You will ensure supplier performance, drive quality compliance, and collaborate with R&D, sourcing, and operations to support customers with reliable products.

The role emphasizes in‑depth knowledge of ISO 13485, Agile practices, and TrackWise, with cross‑functional teamwork to sustain high quality throughout the product lifecycle.

Qualifications

• Bachelor’s degree in related area.
• 4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.
• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• Demonstrated experience on Medical Device Industry or Automotive part qualification requirements.
• Experience using Agile and Trackwise would be a plus.
• Knowledge of ISO 13485 requirements.

Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Partners with cross functional teams (R&D, sourcing, engineering, operations, quality) to deliver quality parts, materials, and services.
• Provides technical guidance and quality compliance throughout the product lifecycle with focus on supplier changes.
• Collaborates with cross functional teams to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, and related quality deployment.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

Skills

Supplier quality

Quality systems

Agile

TrackWise

ISO 13485

Education

Bachelor’s degree in related area

Job description

Quality Consulting Group, LLC seeks a skilled professional to manage supplier quality in a world-class manufacturing context in Puerto Rico and the USA. You will ensure supplier performance, drive quality compliance, and collaborate with R&D, sourcing, and operations to support customers with reliable products.

The role emphasizes in‑depth knowledge of ISO 13485, Agile practices, and TrackWise, with cross‑functional teamwork to sustain high quality throughout the product lifecycle.