Supplier Quality Engineer

Flexible & Integrated Technical Services, LLC • Juncos, PR

54d

About The Position

This role is for Supplier Quality services in the Manufacturing/Engineering area. The ideal candidate will ensure that suppliers deliver quality parts, materials, and services. This includes qualifying suppliers, administering a Certified Supplier Program, monitoring parts through the manufacturing cycle, and resolving supplier-related problems. The role involves evaluating supplier performance, partnering with cross-functional teams to prevent defects and ensure product quality, and providing technical guidance throughout the product lifecycle, with a focus on supplier changes. The position also involves developing strategies for product quality and continuous improvement, defining receiving inspection requirements, and associated test method validation.

Requirements

• Bachelor's degree in Engineering and a minimum of four (4) years of relevant experience, or an advanced degree with a minimum of two (2) years of relevant experience within the medical devices industry.
• Bilingual (English & Spanish).
• Experience using Agile and Trackwise
• Knowledge of ISO 13485 requirements
• FDA QMSR
• Geometric Tolerances
• excellent communication skills
• teamwork
• being ethical

Nice To Haves

• aren’t afraid to ask for help when you need it
• love of the scientific method

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level