Responsibilities:
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Proven experience in managing a Change Management system.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Demonstrated experience in managing ISO-13485, MDSAP, MDR Audits (FDA Inspection experience a plus)
Prepares reports and/or necessary documentation (ex-Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Coordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates standards implementation and enables best practice sharing, thereby fostering the achievement of company’s mission globally.
ISO 13485 Lead Auditor Certification preferred.
Must Have: Minimum Requirements
Bachelor's degree: Industrial Engineering or related.
Master's Degree (preferred)
Minimum 5 year of managerial experience
Full Bilingual (English and Spanish)
Medical Devices Experience
Strong Leadership skills
High Performer and Result Oriented
Please apply in this link
https://medtronic.wd1.myworkdayjobs.com/es/MedtronicCareers/details/Gerente-de-sistemas-de-calidad_R36547-1?q=quality%20system%20manager