Position Summary:

Responsible for release of product to Market and management of device history records. Supports manufacturing in document and quality related issues. Supports QA in SAP functions. Provides metrics regarding OHR review for management review and driving improvement. Maps process and devises new tools to help drive compliance and streamlining of system under direction of management.

Key Accountabilities: 

• Reviews of device history records for release of product to Distribution, including training Manufacturing, Materials and QC personnel in Good Documentation Practices.
• Provides statistics regarding device history record accuracy for all manufacturing teams and Management Review.
• Dissemination of product Certificates of Analysis to all points of distribution.
• Organizes and maintains the Device History Records.
• Organizes quarterly training

Budget Managed (if applicable): N/A

Internal Networking/Key Relationships:

• To be determined based on department needs

Skills & Capabilities:

• Excellent communication and training skills

Min Knowledge & Experience Required for the Position:

• Bachelor's Degree in a scientific discipline or equivalent with minimum 2 years of related Quality Assurance experience
• Working knowledge of ISO Quality Systems and FDA requirements for the Medical Devices Industry;
• Computer literacy including SAP, Excel and PowerPoint
• Understanding of the principles, theories and concepts related to the manufacture and support of Medical Devices

International Mobility: Required: No

Travel Requirements: No

The annual salary range Werfen reasonably expects to pay for the position is $80,000 to $90,000.  Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.