Job Function Quality Job Sub Function Quality Assurance Job Category Professional Location Ciudad Juarez, Chihuahua, Mexico, MX301 – Circuito Interior Norte - BWI Purpose Under general supervision, participate in new and sustaining product/process teams to develop quality‑engineered systems and products, lead and support design verification tests, process validations, and quality processes to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA, and other worldwide regulatory agencies and environmental, health & safety practices. Supports quality assurance activities to ensure effective product quality processes are in place and executed throughout the product lifecycle. Will receive technical guidance on complex problems, but independently develops approaches and solutions. Work is usually well defined, checked for progress, and reviewed for accuracy upon completion. Responsibilities Assist in new product development, sustaining, and supply chain quality projects; develop quality control and risk management plans. Write process and product validation protocols and reports, equipment qualifications, and engineering change orders. Use statistical tools (Six Sigma, SPC, DOE) to analyze data, make acceptance decisions, and improve process capability. Ensure development activities follow design control requirements; product is tested per applicable standards and European Essential Requirements are met per the MDR; product is properly transferred to manufacturing. Support quality improvement opportunities for legacy products, continuous improvement, and customer satisfaction. Plan and ensure effective product acceptance, including inspection instructions, equipment and gage requirements, and sampling plans. Lead vendor audits as technical lead and support Supplier Quality as Franchise Quality representative. Support NC, CAPA, internal audit, training, and QS activities; ensure compliance with due dates. Initiate and investigate Corrective and Preventive Actions (CAPA) as appropriate. Assist in complaint analysis. Assist Regulatory Affairs in developing submissions for process changes, inspection changes, and new devices. Exercise judgment in work details, selections, and engineering alternatives. For supervisory positions, screen assignments for unusual or difficult problems and review techniques and procedures for non‑routine work. Receive general direction on new aspects of assignments. Perform work involving conventional plans, investigations, surveys, structures, or equipment with few complex features. Communicate business‑related issues or opportunities to next management level. Ensure subordinates follow Company guidelines related to health, safety, and environmental practices and have resources needed. Ensure personal and Company compliance with federal, state, local, and company regulations, policies, and procedures. Perform other duties assigned as needed. Qualifications Bachelor’s degree in a related field, along with minimum 2 – 4 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. Master’s degree is preferred. American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable. Familiarity with GD&T concepts is desirable. Ability to develop and implement Quality standards. Some knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices. Some knowledge of or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies. Ability to apply project management skills to fulfill new product development requirements. Problem‑solving skills. Verbal and written communication skills and ability to effectively communicate with internal and external personnel. #J-18808-Ljbffr