Quality Management Specialist
Stefanini North America and APAC - Wyandotte, MI
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Stefanini Group is hiring!Exciting opportunities await, let us help you get started!Click Apply Now or you may Call: 248 263-3904Email: HiteshKumar.Bhatnagar@ for faster processing!Open to W2 candidates!Title: Quality Management Specialist - ContractorLocation: 1609 Biddle Avenue, Wyandotte, MI 48192 United StatesWork schedule: M-F 8:00 AM to 5:00 PMDescription: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 client's products regulated by FDA and USDA.Responsibilities:Ensure compliance within the areas of federal, state, and local regulations for various sites.Work closely with Sales, Marketing, and Technical organizations to facilitate implementation of agreed-upon customer requirements into internal operations.Principal Responsibilities:Manage the customer complaint process, Non-Conformance Management (NCM), and work with investigators and Legal to develop customer letters for product quality NCMs as appropriate.Develop updated NCM system training and provide guidance on trends and opportunities for improvement and insight into customer expectations.Provide FDA with NCM reviews, 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, including disposition, relabeling, repackaging, and disposal of damaged material.Oversee testing and final release of tolled or contract manufactured materials, including traveling to tollers during production runs as needed.Direct experience writing site and division-level processes and procedures (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 teams for labels on imported products and drive disposition decisions.Qualifications:Bachelor's of Science Degree in Engineering, Science, or a related technical field.Minimum 2 years of experience in 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 with multiple touchpoints.Quality Specific Skills:Ability to develop and manage effective relationships in a highly matrixed organization to drive alignment and decisions on Quality topics.Ability to utilize a deep understanding of the process to determine root causes and coordinate the resolution of complaints.Complete more complex customer questionnaires.Ability to work with contract manufacturers and ensure clients and regulatory requirements are fully met.SAP (or other ERP) experience is an asset.Additional Qualifications:Actual job title: Quality Specialist.Quality Auditor and Internal Quality Control responsibilities working with a 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, 5 Whys, Ishikawa.PPAP, APQP knowledge.Customer Specific Requirements.Document Control.Bachelor's degree preferred. Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives. Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.About Stefanini GroupThe Stefanini Group is a global provider of offshore, onshore, and nearshore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are a CMM Level 5 company.
Created: 2025-01-29