The Quality Systems Specialist is responsible for the management of quality systems within the Silicones Division. This role will work directly with the Silicones Division Quality Manager to ensure site and division activities comply with industry standards and any applicable regulations (e.g. EFfCI/GMP, FDA & CFRs, ISO, IATF, Kosher). Work with Group, Divisional, and Regional colleagues on alignment of policies and procedures and drive for continuous improvement of the Integrated Management System (IMS).

Responsibilities include, but are not limited to:

• Supports division Business Teams with the management and completion of quality topics related to customer requests and quality agreement reviews.
• Supports division compliance to existing or new certification/regulatory management efforts, including any integration activities. Maintains all quality system relevant procedures within the IMS and ensures they are current.
• Leads external/customer audit preparation with sites. Conducts internal and vendor audits as needed.
• Risk Management (FMEA and HACCP/HARPC) process oversight. Creates culture of creating and utilizing FMEAs. Ensures there is appropriate training and functional team ownership of the process. Participates in FMEA activities as needed, act as a guide, and continually improve the process.
• Ownership of Food Safety and Food Defense systems for food & cosmetic grade products. Works with site to support programs relating to GMP, Food Safety and Cosmetic regulation compliance.
• Ownership and reporting of other divisional and site programs related to change management, scrap, calibration results.

Essential Functions of this Position:

• Customer/Audit Support
  • Manage/Complete customer agreements (QAAs, TTDs, PPAP) as they apply to quality topics.
  • Complete customer questionnaires/assessments as they apply to quality topics
  • Support Division Quality Manager with audits, including scheduling and coordinating.

• Supports Division Quality Manager with ensuring compliance to existing or new certification/regulatory management efforts, including any site integration activities. (e.g., ISO, GMP, EFfCI, Kosher, FDA)
• Supports all quality system relevant procedures within the IMS and ensures they are current.
• Owner of Food Safety and Food Defense systems. Serves as FDA PCQI.
  • Create and update HACCPs/HARPCs for food grade and cosmetic grade products.
  • Work with QC/QA Manager to support programs relating to GMP, Food Safety and Cosmetic regulation compliance.
  • Host quarterly food safety team meetings and perform annual mock recall.
  • Set up and monitor pest control program.
  • Weekly water quality sampling oversight.
• FMEA process management owner
  • Create culture of creating and utilizing FMEAs.
  • Ensures there is appropriate training and functional team ownership of the process.
  • Participate in FMEA activities as needed, act as a guide, and continually improve the process.
• Product Integrity Support
  • Site lead for Quality e-MoC process
  • Checks for change control agreements on relevant MoC’s
  • Scrap SharePoint ownership and approval process/work flows
  • Review vendor certificates align with final product requirements (Kosher, IATF)

Position Qualifications:

• Bachelor’s degree in a related field required
• 3+ years expereince working with quality systems in a manufacturing environment
• PCQI and GMP certification required
• Knowledge and experience with management systems, with a focus on GMP and EFfCI requirements. Experience with ISO 9001, ISO 13485, or IATF 16949 is also preferred.
• Proficient in leading and driving projects independently with effective time management
• Experience using an ERP system, preferably SAP
• Proficient in Microsoft Office applications and data analysis
• Preferred experience with Quality Management / Quality Assurance functions including document management, risk management (FMEA), problem solving, auditing, contract reviews
• Ability to partner at all levels of the organization
• Able to work independently and collaborate proactively within a matrix team organization. Able to interact with upper management.
• Professional communication and messaging skills, as well as listening. Able to adapt message to suit audience.
• Minimum of 10% travel

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement