Provides oversight for the development and maintenance of quality programs, systems, processes and procedures to ensure compliance with policies and standards
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
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
Prepares reports and necessary documentation (e.g., Corrective and Preventative Actions) and provides to applicable stakeholders
Co-ordinates legal requests in support of government investigations or litigations
Ensures the quality assurance programs and policies are maintained and modified regularly
Facilitates uniform standards worldwide and enables best practice sharing
Manages, mentors, develops and coaches staff; conducts performance reviews and 1:1s; authorizes hiring, firing, promotion and rewards within own area
Requirements
Requires a Baccalaureate degree (Bachelor degree): Industrial Engineering or related
Minimum of 5 years relevant experience (or advanced degree with a minimum of 3 years prior relevant experience)
Minimum 5 year of managerial experience
Full Bilingual (English and Spanish)
Medical Devices Experience
Strong Leadership skills
High Performer and Result Oriented
Practical knowledge in leading and managing the execution of processes, projects and tactics within one job area
Advanced knowledge and skills within a specific technical or professional discipline
People management experience (managing subordinate supervisors and/or experienced professionals, typically six or more direct reports)