Sr. Supplier Quality Engineer

Flexible & Integrated Technical Services, LLC • Juncos, PR

19d • Remote

About The Position

This role is for Supplier Quality services in the Manufacturing/Engineering area. The Technical Part requires a Bachelor's degree in Engineering and 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. Bilingual (English & Spanish) is required. The work type is Remote and the shift is Administrative and according to business needs. Experience in Distribution Centers and 3PL's suppliers, and Leading Projects is needed. SAP, Agile and Trackwise are desired. The Personality Part emphasizes excellent communication skills, willingness to ask for help, a love of the scientific method, teamwork, and ethical conduct.

Requirements

• Bachelor's degree in Engineering and 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.
• Bilingual (English & Spanish).
• Experience in Distribution Centers and 3PL's suppliers.
• Experience in Leading Projects.
• Excellent communication skills.
• Ethical conduct.

Nice To Haves

• SAP
• Agile
• Trackwise

Responsibilities

• Support the Supplier and Distribution Quality organization to identify and establish the Approved Supplier List (ASL) for Distributors and 3PL's, negotiate Quality Agreements, monitor the performance, develop and execute the audit schedule, as well as supporting on validation and qualification activities with these suppliers.
• 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 through the Supplier CAPA process.
• 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.
• 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, Post-Market Supplier Quality and Distribution Teams, to deliver quality parts, materials, and services, prevent defects, to provide customers with the highest quality and reliable products.
• Collaborates with Distribution in the selection of new Distributors and 3PLs.
• Define Receiving Inspection requirements as required and associated test method validation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior