Supplier Quality Engineer II

fitspr; Puerto Rico; On-site; USD 75,000 - 110,000; Full time

Job summary

FITS is seeking an Engineer for services in the Manufacturing area. The role focuses on supplier quality, GMP adherence, and Pre-Market Support for new products. Bilingual in Spanish and English with a Engineering degree and 3 years in Medical Devices are required.

Responsibilities include auditing suppliers, qualifying vendors, and ensuring continued quality and compliance throughout the manufacturing cycle, with a customer-family oriented culture at the core.

Qualifications

• Bachelor’s degree in Engineering required.
• Minimum 3 years of experience in the Medical Devices industry.
• Bilingual in Spanish and English.
• Strong writing and communication skills.
• Shift: 1st shift; flexible as needed.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers per standards; may run a Certified Supplier Program.
• Audit designated suppliers to GMP and quality standards.
• Assess supplier performance and provide feedback.
• Provide Pre-Market Quality support for NPD with cross-functional teams.
• Guide quality compliance for Supplier Quality across the NPD lifecycle.
• Collaborate on Product Acceptance Sampling Strategy and Control Plans.

Skills

Bilingual Spanish/English

Writing skills

Communication skills

Problem solving

Root cause analysis

Process validation

Computer software

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-relatedproblems 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: ProvidesPre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the ComponentEngineering 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 onnewly 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 industrystandards, regulatory requirements, and customer requirements.
• Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approvedsupplier 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 MedtronicTest Methods.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves on 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 Devic,e and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?