Location: San Jose, California
This role leads the global business processes related to complaint handling, regulatory reporting and supports the post-market product surveillance activities. Provide leadership and subject matter expertise to ensure that an effective system is successfully implemented and maintained. This position is a leadership role within the organization and is accountable for identifying and championing sustainable business process improvements, improving products, and providing management with actionable business and product data. This role requires exceptionally strong communication, interpersonal and organizational skills and a solid understanding of the application of FDA and ISO 13485 standards.
Ability to read and interpret complex quality documents.
Ability to apply and understand basic arithmetic operations.
Ability to identify potential problems and discuss findings with Quality Management.
Working knowledge of desktop computer and software programs.
No certifications needed
Post Market Surveillance Coordinator, Analysts and Supervisor report to this position.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is also required to stand; walk; use hands to finger, handle or feel and reach with hands and arms. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus.