Supplier Quality Engineer II

FITS, LLC; Villalba (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

FITS, LLC is looking for an Engineer in the Manufacturing area located in Villalba, Puerto Rico. The ideal candidate should hold a Bachelor’s Degree in Engineering and have at least three years of experience in the Medical Devices Industry. Bilingual skills in Spanish and English are essential.

This role involves ensuring quality delivery from suppliers, qualifying suppliers, and providing compliance support throughout the product lifecycle. Strong problem-solving skills, communication abilities, and a collaborative mindset are crucial.

Qualifications

• 3 years of experience within the Medical Devices Industry.
• Experience in Process Validation and Computer Software.
• Shift availability according to business needs.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards.
• Develop and prioritize an auditing schedule for suppliers.
• Evaluate suppliers' internal functions and provide feedback.
• Provide Pre-Market Quality Engineering support in NPD.
• Provide technical guidance for Quality compliance.
• Collaborate with Component Engineers for product strategies.
• Define Receiving Inspection requirements and test validations.

Skills

Bilingual: Spanish and English

Writing and communication skills

Problem-Solving Techniques

Root Cause Analysis

Computer proficiency

Education

Bachelor’s Degree in Engineering

Job description

For Engineer services in the Manufacturing area.

What Makes You a Fit

The Technical Part

• Bachelor’s Degree in Engineering and three (3) yearof experiencewithin the Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Writing and communication skills
• Shift: 1st and according to business needs.
• Experience in:
  • Computer proficiency
  • Problem-Solving Techniques
  • Root Cause Analysis
  • Process Validation and Computer Software.

The Personality Part

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

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.
• 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 theiroperation.
• Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: 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.