Bilingual Supplier Quality Engineer - Medical Devices

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

Job summary

FITS LLC in Puerto Rico (Juncos) seeks a Supplier Quality professional to ensure quality parts, materials, and services from suppliers in the medical devices sector.

The role requires a engineering degree, several years of experience, bilingual English/Spanish, and familiarity with ISO 13485, FDA QMSR, and Trackwise, working with cross-functional teams to prevent defects and drive continuous improvement.

Qualifications

• Bachelor's degree in Engineering and a minimum of four years of relevant experience, or an advanced degree with a minimum of two years of relevant experience within the medical devices industry.
• Bilingual (English & Spanish).
• Shift: Administrative and according to business needs.
• Experience using Agile and Trackwise.
• Knowledge of ISO 13485 requirements.
• FDA QMSR.
• 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 in receiving inspection to ensure cost effectiveness.
• Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Partners with cross functional teams (R&D, sourcing, engineering, operations, quality), to deliver quality parts, materials, and services, prevent defects, and allow MiniMed to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance throughout the product lifecycle (with focus on supplier changes) and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
• Collaborates with cross functional teams to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
• Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.

Skills

Bilingual (English & Spanish)

Agile

Trackwise

Geometric tolerances

Quality systems knowledge

Education

Bachelor's degree in Engineering

Advanced degree in Engineering (or related field)

Tools

TrackWise

Job description

FITS LLC in Puerto Rico (Juncos) seeks a Supplier Quality professional to ensure quality parts, materials, and services from suppliers in the medical devices sector.

The role requires a engineering degree, several years of experience, bilingual English/Spanish, and familiarity with ISO 13485, FDA QMSR, and Trackwise, working with cross-functional teams to prevent defects and drive continuous improvement.