Microbiologist I - 31116

Apply by eMail:15221263.185@jobfrenzy1.com

Description:
Position Purpose:

Provide oversight of assigned Sterilization Department objectives and related technical support of Corporate Sterilization objectives.

Customers:

Divisional Manufacturing Team Members, Quality Teams, Research and Development, Contracted Sterilization Companies and Regulatory Affairs.

Expectations:

- Manage the sterilization aspects of new product developed at Maple Grove; sterilization evaluation documents, ethylene oxide deliverables, and sterilization technology direction objectives are set, monitored, and completed in proper priority.

- Consult on sterilization and quality issues, support problem solving and resolution, and provide counsel to customers for related sterilization testing needs.

Scope:

The position reports to the Manager of Corporate Sterilization.

This position is responsible to manage Sterilization and Microbiology related projects in a variety of areas with little direction and need for oversight of time management. The Sterilization Microbiologist will function as a project manager for assigned department programs. This position insures that strategic decisions as well as key technical decisions for sterilization are documented and implemented.

Ensures that all programs and documentation comply with internal/external standards and regulations. Acts as primary contact between Corporate Sterilization Services and Product Development Teams.

Requirements:
Qualifications/Education/Experience Required:

This position requires knowledge and ability typically associated with a Bachelor's degree in microbiology or related science, with 0-3 years of medical device or sterilization experience.

Principal Accountabilities:

75% Improve and manage validation systems and assure quality and compliance related information and data is accurate, reliable, and supports business objectives.

• Develop, implement and maintain documentation systems, procedures and document formats to support product development programs. Assure compliance with applicable standards, guidelines, corporate policies and regulatory requirements.

• Conduct or assist with sterilization product qualifications, data analysis, and report generation as required, assuring compliance with applicable standards, guidelines, policies and regulations.

• Assist with the generation of regulatory documentation and review of product submissions.


25% Perform the duties of a sterilization microbiologist for studies conducted by the department to support compliance with operational needs.

Education: Bachelor

Experience: At Least 3 Years

Travel: None

Apply by eMail:15221263.185@jobfrenzy1.com

Job Created: Thu Sep 24 2009 04:27:15 AM
Last Modified: Thu Sep 24 2009 04:27:15 AM