Supplier Quality Engineer I

Flexible & Integrated Technical Services, LLC • Villalba, PR

19h • Onsite

About The Position

This role is for Engineering services in the Manufacturing area. The ideal candidate will ensure that suppliers deliver quality parts, materials, and services. This includes qualifying suppliers according to company standards, potentially administering a Certified Supplier Program, and monitoring parts throughout the manufacturing cycle. The role involves developing and prioritizing an auditing schedule to ensure suppliers meet Good Manufacturing Practices (GMP) and quality standards, as well as evaluating suppliers' internal functions and providing feedback. Some individuals may also provide Pre-Market Quality Engineering support for New Product Development (NPD), collaborating with Component Engineering and Post-Market Supplier Quality Teams to ensure quality parts, prevent defects, and deliver reliable products. This includes providing technical guidance and quality compliance for supplier engagement throughout the NPD lifecycle, defining strategies for product quality and continuous improvement, and ensuring purchased products meet industry standards, regulatory requirements, and customer requirements. Collaboration with Component Engineers on Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products is also a key responsibility. Defining Receiving Inspection requirements and associated test method validation is also part of the role.

Requirements

• Bachelor’s Degree in Engineering
• Four (4) years of experience within the Medical Devices Industry.
• Bilingual: Spanish and English
• Writing and communication skills
• Computer proficiency
• Problem-solving techniques

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.
• Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD 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 Component Engineers 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: Entry Level