Quality Assurance Systems Leader

hace 2 meses


Juárez, Chihuahua, México Medtronic A tiempo completo
Transforming Lives Through Quality Assurance

Overview of Responsibilities

The following responsibilities are integral to this role:

Oversees the formulation and upkeep of quality assurance programs, frameworks, processes, and protocols to ensure adherence to policies and that service performance meets established internal and external benchmarks. Offers expert advice and direction in understanding policies, regulatory requirements, and internal guidelines to guarantee compliance. Demonstrated proficiency in managing a Change Management framework. Collaborates directly with operational units to provide ongoing process analysis oversight to enforce compliance and meet regulatory standards. Directs audit and inspection readiness, addresses audit and inspection outcomes, and coordinates with auditing bodies and inspectors throughout the audit process. Proven experience with ISO-13485, MDSAP, and MDR Audits (experience with FDA inspections is advantageous). Compiles reports and necessary documentation (e.g., Corrective and Preventative Actions) for relevant stakeholders, both internal and external. Manages legal inquiries in support of governmental investigations or legal proceedings. Ensures that quality assurance programs and policies are consistently maintained and updated. Promotes standardized practices globally and facilitates the sharing of best practices, thereby supporting the achievement of the company's global mission. Lead Auditor certification is preferred. Essential Qualifications

A Bachelor's degree is required. A minimum of 5 years of relevant experience, or an advanced degree with at least 3 years of relevant experience. Preferred Qualifications


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