Quality Management Specialist I

Job Title- Quality Management Specialist I

Location- Wyandotte, MI 48192

Duration- 12 months

Pay Rate- $26/hr.

Shift- 8am to 5pm

Job Description

Quality Management Specialist - CONTRACTOR Description 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. 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 - Multiple touch points Quality Specific Skills- • 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 *** and 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

Quals--

Actual job title: Quality Specialist.

Quality Auditor and Internal Quality control responsibilities working with team to help solve quality issues. Internal auditor with IATF/ISO certification

Auditing Experience IATF 16949/ ISO 9001 VDA 6.3 preferred

Root Cause Problem solving 8D, 5why, Ishikawa

PPAP, APQP knowledge

Customer Specific Requirements

Document Control

Bachelor’s degree preferred