[ref. s61521920] Compliance Specialist II

Overview:

Position Summary:

Maps process and devises new tools to help drive compliance and streamlining of system under direction of management.

Responsibilities:

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

Qualifications:

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 $95,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.