Overview
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.
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.
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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 $90,000. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.