New Quality System Assessment Creation and Implementation
FDA Remediation
ISO 13485 certification preparation
Strategic Suppliers Controls program
Total QMS management including:
Design, Supplier, Document, and Engineering Controls
Corrective and Preventative Action (CAPA)
Nonconforming product and Inspection/ Acceptance activities
Complaint Handling and MDR reporting
Auditing programs
Strategic and holistic Risk Management Programs
Process Validations Assessing, Planning, and Execution
Effective Quality Planning and Process Mapping


Maintaining compliant Quality Management Systems
Supplier and Internal Auditing
QMS documentation
Supplier evaluations
Control Plan Generation
Integration teams for mergers and acquisitions
Data entry for quality system software programs



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