Senior Quality Systems Supervisor
Medtronic · Coyol
Descripcion del puesto
About the role
Medtronic is seeking a Senior Quality Systems Supervisor to lead and strengthen the quality system at its manufacturing plant. The role ensures regulatory compliance, drives continuous improvement, and supports audit activities while maintaining high standards for patient safety and product quality.
Key responsibilities
- Develop, maintain, and oversee quality programs, systems, processes, and procedures in line with internal and external standards.
- Interpret and apply regulatory requirements such as ISO 13485, FDA QMS regulations, and internal policies.
- Provide ongoing process analysis and oversight to enforce compliance across operating entities.
- Lead audit and inspection preparation, manage findings, and coordinate with auditors and inspectors.
- Prepare corrective and preventive action documentation and communicate results to stakeholders.
- Support legal requests for government investigations or litigation.
- Facilitate global uniform standards and best‑practice sharing.
Required profile
- Bachelor’s degree or equivalent in industrial, chemical, electronic engineering or a related field.
- Minimum six years of relevant quality systems experience in a regulated environment.
- Proven leadership and management capabilities.
- Advanced English proficiency.
Required skills
- Quality Management System (QMS) expertise.
- ISO 13485 knowledge.
- FDA regulatory and QMSR familiarity.
- CAPA and non‑conformance (NC) management.
- Audit planning and execution.
- Risk management.
- Lean and Six Sigma methodologies (Green/Black Belt preferred).
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Publicado hace 10 horas
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Medtronic
Coyol