Kloudhire

DUTIES AND RESPONSIBILITIES (essential functions of position):

Nothing in this job description restricts managementâ??s right to assign or reassign duties and responsibilities to this job at any time.
Provide overall direction to the following functions: Customer Complaints, Internal Audits, CAPA, Document Control, Quality Engineering, Supplier Quality and Employee Training.
Drive continuous improvement and optimization of the Quality Management System and supporting processes.
Ensure new/emerging regulatory requirements are identified and effectively incorporated into the Quality Management System.
Interface with ISO Registrar, Authorized Representative and government agencies, as necessary.
Oversee the development of the department staff and infrastructure.
Develop and manage the department budget.
Regular attendance required.

ESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS:

5 or more years experience as a Quality Systems Director or Manager.
Full understanding of U.S. FDA a??s Quality System Regulations (21 CFR 820), ISO 13485 and ISO 14971 requirements.
U.S. FDA establishment inspection experience.
4 year degree or higher required.

NONESSENTIAL SKILLS, EXPERIENCE AND QUALIFICATIONS (not necessary but preferred):N/A

SUPERVISORY RESPONSIBILITIES:

PHYSICAL DEMANDS AND WORK CONDITIONS:

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.
Regularly required to sit for extended periods of time; frequently required to stand, walk and use business equipment daily such as P.C., copier, fax, telephone, etc.; occasionally required to reach overhead, bend, and lift objects of up to 20 lbs.