Job Summary: Manage and coordinate quality system activities such as nonconformities, CAPA, change controls, and product release, providing timely feedback and follow-up. Key Highlights: 1. Lead quality systems in a global medical technology company. 2. Promote continuous improvement in business systems and processes. 3. Support audits for compliance with regulatory frameworks. **Job Description Summary** =========================== Manage and coordinate all related activities to ensure timely and effective compliance with quality systems under the incumbent’s area of responsibility—including internal and external nonconformities/CAPA, change controls, and product release—providing timely feedback and follow-up to stakeholders.**Job Description** =================== Do you want to join a global leader in medical technology that acts to advance the world of health? Be part of something great! BD is one of the world’s largest medical technology companies. We hold a unique market position with solutions designed to improve disease management and care delivery, supporting customers, healthcare professionals, and patients in enhancing clinical practice. Globally, we have over 65,000 employees passionate about what we do and committed to advancing the world of health with solutions spanning from diagnosis to treatment. Diagnostics Solutions (DS) By aligning and simplifying our work, our Diagnostics Solutions (DS) business unit aims to drive growth and innovation across everything—from integrated sample management to diagnostic solutions. **Quality Engineer** Manage and coordinate all related activities to ensure timely and effective compliance with quality systems—including nonconformities, CAPA, complaints, change controls, and product release—providing timely support and follow-up to stakeholders. Key Responsibilities: * Monitor corrective and preventive action (CAPA) processes by overseeing the system and facilitating meetings with stakeholders to ensure compliance with applicable and current regulatory requirements for DS. * Implement and support plant-based projects to improve various business systems and processes, ensuring adherence to established policies and procedures. * Support responses to internal and external audits by providing information to auditors and following up on and closing identified findings or opportunities for improvement to ensure regulatory compliance. * Manage the DS Documentation and Release team, ensuring achievement of defined objectives, compliance with internal procedures, and fulfillment of internal customer requirements to sustain process continuity. * Develop and coordinate documentation staff to achieve their objectives within the company. * Coordinate and track customer complaints. * Support maintenance of quality master data in SAP. * Coordinate the Change Control process. Education and Experience Requirements: * Chemical Engineer, Bacteriologist, Microbiologist, Pharmacist-chemist (QFB), Pharmacist-biologist (QBP), Biochemist-Biologist, or related field. * 2 years of experience in Quality or Manufacturing roles. * Advanced English proficiency. Professional Skills: * Service-oriented attitude * Results-driven * Teamwork with customer focus * Influence over others * Results-oriented Desired Additional Skills and Knowledge: * Project management * Statistics or sampling tables * SAP and/or Trackwise proficiency * Knowledge of healthcare regulations (e.g., ISO 13485, NOM-241, NOM-059, ISO 9001, etc.) *“At BD, we provide equal opportunity to all candidates and associates regardless of gender, age, visible or non-visible temporary or permanent disability, ethnicity, race, religion, appearance, sexual orientation, gender expression or identity, occupation, personal style, marital status, as well as individuals holding diverse opinions, perspectives, lifestyles, ideas, and ways of thinking and being. Abuse or discrimination toward or by a BD associate is unacceptable.”* Required Skills Optional Skills . **Primary Work Location** ========================= MEX Cuautitlan Izcalli**Additional Locations** ======================== **Work Shift** ==============