Global manufacturer has an opening for a contract Quality Management Specialist I at their Wyandotte, MI, site.

**THIS IS A LONG TERM CONTRACT POSITION WITH POSSIBILITY OF DIRECT HIRE FOR THE RIGHT CANDIDATE AND A PAY RATE OF $ 34.00/HOUR.**

The position of the Quality Management Specialist for Nutrition and Health is designed to provide support to various plants, laboratories, warehouses, and tolling operations that manufacture, test, or handle  products regulated by FDA and USDA. Ensures compliance within the areas of federal, state, and local regulations for various sites. Works closely with Sales, Marketing, and Technical organizations to facilitate implementation of agreed upon customer requirements into internal operations.

Individual needed with strong IT focus to help digitize the quality systems and identify various internal and external IT applications within Cellasto. 
Excellent working knowledge of Excel, PowerPoint and Visio. PowerBI experience a plus. 

Ability to use quality data to enable cross functional team to drive improvements. Knowledge of FMEA, Control Plan, internal auditing a plus.

Ability to develop and manage effective relationships in a highly matrix organization to drive alignment and decisions on Quality topics.

Ability to utilize a deep understanding of the process to determine root case and coordinate resolution of complaints.

Completes more complex customer questionnaires.

Ability to work with contract manufacturers and ensure regulatory requirements are fully met.
SAP ( or other ERP ) experience an asset. 

Principal Responsibilities

Manage customer complaint process, Non-Conformance Management (NCM), process with investigators and work with Legal to develop customer letter for product quality NCMS as appropriate.

Develop updated NCM system training and provide the businesses guidance on trends and opportunities for improvement and insight to customer expectations.
Provide FDA with NCM review, as needed.

Work with EHS Management Systems (Responsible Care Management System RCMS)

Conduct training for the business, customer care, and manufacturing sites concerning QM/EHS related topics

Advise on the North American Kosher and Halal programs, as appropriate.

Provide QA oversight for warehousing activities - disposition, relabeling, repackaging and damage material disposal 

Oversee testing and final release of tolled or contract manufactured materials. Includes traveling to tollers during production runs as needed. 

Direct experience writing site and division level processes and procedures (have basic knowledge of laboratory practices at sites)

Label and technical document approval responsibilities, specifically for contract and tolled materials

Act as the Manufacturing Site's QA Liaison

Interact with global for labels on imported products and drive disposition decisions   

Work Schedule: Monday - Friday (8 AM - 5 PM)

Required Qualifications  

Bachelors of Science Degree in Engineering, Science or related other technical field

Minimum 2 years experience in a quality and/or product regulations with the ability to understand and interpret FDA, USDA and other quality and regulatory requirements.

Strong written and oral communication, analytical, problem solving and organizational skills.

Ability to work independently and assist internal, as well as external customers

Receptive to change and innovation with the ability to identify areas for improvement

Able to multi-task and maintain a professional approach in a fast-paced business environment

Skilled at working within a multi-functional organization -