Location
Illinois | United States
Job description
The Quality Systems Manager (QS Manager) ensures Quality is incorporated into the foundations of everything we do and through the life cycle of the products we create. This individual manages the design, creation, publication, and maintenance of the procedures, processes, and programs - which in turn drive Quality and Engineering systems to comply with hygienic standards and best practices. Pivotal to this role is identifying appropriate measures of system effectiveness and ensuring these are implemented and monitored.
Essential Duties and Key Responsibilities :
- Manages the overarching quality system including the development, deployment and maintenance of the Organization's Quality Policy Manual and associated SOPs
- Lead and manage the QMS process from R&D through operations
- Responsible for Customer Facing HCQM contact, ensuring Customer needs are met. Key contact for customer audits, document requests and routine communications
- Manage and application of the Quality Monitoring Scheme (QMS) which documents the quality requirements for each product manufactured and ensure alignment to the MSPEC starting with R&D through manufacturing
- Customer Facing QA contact for our customers and ensures that customer requirements are translated into the quality system, communicated within the organization as required and customer needs are met
- Responsible for KPI development and reporting for the QA Department and manages shelf-life monitoring and extensions for both raw materials and finished products
- Responsible for document control, Pest Control, Management of Change, KPI reporting and follow-up and shelf-life monitoring and extensions
- All other duties as assigned
Qualifications
- Bachelor's degree in Food Science, Food Engineering, Chemistry or related field required
- 10+ years of experience in a cGMP environment
- Experience with manufacturing of aseptic products and thermal processing
- Knowledge of system design and experience working with implementing robust sustainable programs
- Enjoys project work and wants to make a difference by implementing best-in-class quality and engineering systems
- Recognizes process waste and leads others to drive improvement
- Familiar with and use of Lean Six Sigma tools to drive improvements in systems and process Belt or Black Belt preferred
- Identify stake-holders and communicate effectively both verbally and in writing to all levels of the organization
- Ensure Quality by Design from ideation through commercialization
- Manages the overarching quality system including the development, deployment and maintenance of Internal Prerequisite Programs and associated SSOPs
- Develop and implement Engineering systems to manage buildings and equipment, through their life-cycle including - adoption of new technologies, testing and validation of equipment, and obsolescence
- Participates in and provides input to design of products and processes
- Drive Quality in Execution
- Enhances accessibility and utilization of the Quality Monitoring Scheme (QMS) which documents the quality requirements for each product manufactured and ensure alignment to the MSPEC
- Act as the customer facing HCQM contact Ensure that customer requirements are translated into the quality system, communicated within the organization as required and customer needs are met
- Prepares for and represents organization as primary contact for all customer audits
- Responsible for KPI development and reporting for the QA Department and manages shelf-life monitoring and extensions for both raw materials and finished products
- Responsible for document control, Pest Control, Management of Change, KPI reporting, shelf-life monitoring and extensions
- Perform all other duties as assigned
Job tags
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