Senior Supplier Quality Engineer Medical Devices Compliance

fitspr; Juncos (PR); On-site; USD 75,000 - 105,000; Full time

Job summary

FITS is seeking a Supplier Quality professional for the Manufacturing/Engineering area to ensure supplier quality across parts, materials, and services for medical devices.

Requirements include a Bachelor's degree in Engineering with 4+ years in medical devices experience, or an advanced degree with 2+ years, plus bilingual English/Spanish.

You will collaborate with R&D, sourcing, engineering, operations and quality teams to drive product quality, supplier performance, and continuous improvement.

Qualifications

• Bachelor's degree in Engineering with 4+ years in medical devices or an advanced degree with 2+ years.
• Bilingual English/Spanish required.
• Experience using TrackWise and knowledge of ISO 13485, FDA QMSR, and geometric tolerances.

Responsibilities

• Ensures that suppliers deliver quality parts, materials, and services.
• Qualifies suppliers according to company standards and may administer a Certified Supplier Program.
• Monitors supply parts through the manufacturing cycle and resolves supplier-related problems.
• Evaluates suppliers' internal functions and provides feedback on operations.
• Collaborates with cross-functional teams (R&D, sourcing, engineering, operations, quality) to deliver quality and reliable products.
• Provides technical guidance and quality compliance throughout the product lifecycle and implements improvement strategies.
• Develops and delivers the Product Acceptance Sampling Strategy and related supplier quality activities.
• Defines Receiving Inspection requirements and test method validation for internal Medtronic methods.

Skills

Communication skills

Teamwork

Bilingual English/Spanish

Maintenance skills

Education

Bachelor's degree in Engineering

Advanced degree in Engineering

Tools

TrackWise

ISO 13485

FDA QMSR

Geometric tolerances

Job description

FITS is seeking a Supplier Quality professional for the Manufacturing/Engineering area to ensure supplier quality across parts, materials, and services for medical devices.

Requirements include a Bachelor's degree in Engineering with 4+ years in medical devices experience, or an advanced degree with 2+ years, plus bilingual English/Spanish.

You will collaborate with R&D, sourcing, engineering, operations and quality teams to drive product quality, supplier performance, and continuous improvement.