Supplier Quality Engineer

FITS, LLC; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

FITS, LLC provides supplier quality services in the Manufacturing and Engineering area, focusing on medical devices. You will ensure supplier quality and compliance across parts, materials, and services, while coordinating with R&D, sourcing, engineering, and operations to prevent defects and maintain high product quality.

The role involves evaluating suppliers, applying corrective actions, and supporting continuous improvement in accordance with industry standards and customer requirements.

Qualifications

• Bachelor's degree in Engineering with 4+ years of relevant experience, or advanced degree with 2+ years in medical devices.
• Shift is administrative and per business needs.
• Experience with Agile and Trackwise; knowledge of ISO 13485 requirements, FDA QMSR, and geometric tolerances.

Responsibilities

• Ensures suppliers deliver quality parts, materials, and services.
• Qualifies suppliers per company standards and may administer a Certified Supplier Program.
• Monitors parts from acquisition through manufacture and resolves supplier issues.
• Evaluates supplier internal functions and provides performance feedback.
• Collaborates with cross-functional teams to ensure quality and regulatory compliance.
• Provides guidance on quality compliance throughout the product lifecycle and supplier changes.
• Helps develop and deliver Product Acceptance Sampling Strategy and Approved Supplier List processes.
• Defines receiving inspection requirements and validation for internal test methods.

Skills

Communication skills

Teamwork

Maintenance skills

Quality mindset

Education

Bachelor's degree in Engineering

Advanced degree

Tools

Trackwise

ISO 13485 requirements

FDA QMSR

Geometric tolerances

Job description

For Supplier Quality services in the Manufacturing/Engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's degree in Engineeringand 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.
• Shift: Administrative and according to business needs
• Experience in:
  • Experience using Agile and Trackwise
  • Knowledge of ISO 13485 requirements
  • FDA QMSR
  • Geometric Tolerances

The Personality Part:

• If you have excellent communication skills and aren’t afraid to ask for help when you need it (in addition to your excellent Maintenance skills), this might be the job for you! Sprinkle on a love of the scientific method, teamwork, and, above all else, being ethical, and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!