Sr. Supplier Quality Engineer

FITS, LLC; Juncos (PR); Hybrid; USD 70,000 - 100,000; Full time

Job summary

FITS, LLC is seeking a Supplier Quality professional for our Manufacturing/Engineering area in a hybrid role. The candidate will support supplier qualification, audits, and CAPA processes across distributors and 3PLs, ensuring GMP and quality standards are met throughout the NPD lifecycle.

Ideal candidates have an engineering degree, 4+ years in medical devices, and experience with SAP/TrackWise. Willingness to travel to external manufacturers is required.

Qualifications

• Bachelor's degree in Engineering and 4+ years of relevant experience, or an advanced degree with 2+ years in medical devices.
• Experience with SAP and TrackWise is desirable.
• Knowledge of GMP and regulatory standards is preferred.

Responsibilities

• Support the Supplier and Distribution Quality organization in ASL, QA agreements, supplier performance, audits, and validation activities.
• Qualify suppliers per company standards and administer a Certified Supplier Program as needed.
• Monitor parts and materials from procurement through manufacturing, via the CAPA process.
• Develop supplier audit schedules and ensure GMP compliance and quality standards.
• Evaluate supplier performance and provide recommendations on operations.
• Provide Pre-Market Supplier Quality Engineering support for NPD in collaboration with other functions.

Skills

Engineering Degree

Communication Skills

GMP Knowledge

Problem Solving

Education

Bachelor's degree in Engineering

Tools

SAP

TrackWise

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.
• Work Type: Hybrid
• Shift: Administrative and according to business needs
• Experience in:
  • Distribution Centers and 3PL's suppliers
  • Leading Projects
  • SAP, Agile and Trackwise desired.

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)

• Support the Supplier and Distribution Quality organization in identifying and establishing the Approved Supplier List (ASL) for Distributors and 3PLs, negotiating Quality Agreements, monitoring supplier performance, developing and executing audit schedules, and supporting supplier validation and qualification activities.
• Qualify suppliers according to company standards and may administer a Certified Supplier Program within Receiving Inspection to ensure cost-effectiveness.
• Monitor parts, materials, and services from acquisition through the manufacturing cycle and communicate and resolve supplier-related problems through the Supplier CAPA process.
• Develop and prioritize supplier audit schedules to ensure designated suppliers are audited regularly and comply with Good Manufacturing Practices (GMP) and applicable quality standards.
• Evaluate suppliers’ internal functions and overall performance, providing feedback and recommendations regarding their operations.
• Provide Pre-Market Supplier Quality Engineering support for New Product Development (NPD), working in partnership with Component Engineering, Post-Market Supplier Quality, and Distribution teams to prevent defects and ensure the quality and reliability of parts, materials, and services.
• Collaborate with Distribution in the selection of new Distributors and 3PLs.
• Define Receiving Inspection requirements as required, including associated test method validation.
• Provide technical guidance and ensure quality compliance throughout the Supplier Quality engagement across the NPD lifecycle for newly qualified parts.
• Implement strategies to drive product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Collaborate 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.
• Availability to travel to visit external Contract Manufacturers and Suppliers.

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!