Primary Responsibility: Support and assist the Compliance Manager with the daily compliance and quality functions. This includes the maintenance and execution of Regulatory Affairs, auditing, data analysis, report writing and other special assignments.
Specific Responsibility Expectation
|
Auditing
|
Perform internal audits and supplier audits as needed. Possible on-site visits to suppliers. Prepare and assist with Audit Planning.
|
|
Regulatory Requirements
|
Research, understand and monitor Regulatory Requirements and changes to these requirements that affect Full Vision and the QMS. Communicate these requirements throughout the organization.
|
|
Regulatory Documents
|
Research, develop and prepare regulatory documents for signature and submitting to Customers and Regulatory authorities. Communicate as needed with suppliers, customers and regulatory authorities on regulatory requirements.
|
|
Quality Management System
|
Assist the Compliance Manager with managing the Full Vision QMS including document control, developing, modifying and implementing quality documents and maintaining the ISO certifications.
|
|
Customer Satisfaction
|
Assist the Compliance Manager with managing Customer Complaints. Work with customers on quality issues, complaints and corrective/preventive action. Possible on-site visits to customers.
|
|
Quality Improvement
|
Work with manufacturing and engineering on continuous improvements for Quality, Efficiency and Safety.
|
|
Data Analysis
|
Perform data analysis per regulatory and ISO standards; internal quality and performance metrics; and communicate trends to management.
|
|
Training
|
Perform and assist with regulatory and ISO standards, industry best practice, and internal process and procedure training.
|
