Sr. Supplier Quality Engineer

Flexible & Integrated Technical Services, LLC • Juncos, PR

1d • Hybrid

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 Hybrid with Administrative shift and according to business needs. Experience in Distribution Centers and 3PL's suppliers, 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
• Teamwork
• Ethical conduct

Nice To Haves

• SAP
• Agile
• Trackwise

Responsibilities

• 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.

What This Job Offers

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