Demo

Quality Specialist

Synectics
Wyandotte, MI Full Time
POSTED ON 3/20/2025
AVAILABLE BEFORE 4/20/2025

Responsibilities :

  • 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.
  • Manage customer complaint process, Non-Conformance Management (NCM), process with investigators and work with Legal to develop customer letter for product quality NCMS
  • 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
  • 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
  • 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
  • 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
  • Quality Auditor and Internal Quality control responsibilities working with team to help solve quality issues.

Qualifications :

  • Bachelors of Science Degree in Engineering, Science or another related technical field preferred
  • 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.
  • 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
  • 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
  • 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.
  • Benefits :

    Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

    Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

    Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

    Synectics is an equal opportunity employer.

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