FITS, LLC

• Lead and manage the full sterilization project portfolio, including new product launches, validations, revalidations, and process improvements • Develop and maintain integrated project plans, timelines, resource maps, and risk registers • Drive cross-functional alignment across R&D, Quality, Regulatory, Operations, and Supply Chain • Facilitate portfolio-level prioritization and trade-off decisions with senior leadership • Establish and report on KPIs, milestones, and program health metrics • Serve as subject matter expert (SME) for EO sterilization processes including supporting microbiological/chemical methods • Ensure compliance with international regulations • Coordinate with internal cross-functional partners to support relationships with contract sterilizers and laboratory service providers

Senior Supplier Quality Engineer Location: Juncos, Puerto Rico Remote Contracted Medical devices Experienced For Supplier Quality services in the Manufacturing/Engineering area. WHAT MAKES YOU A FIT: The Technical Part: - 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). - Work Type: Remote - 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 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.