Quality Systems Manager

Company: Affinity Executive Search
Location: Indianapolis
Posted on: September 20, 2023

Job Description:

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 companies Quality Policy Manual and associated SOPsLead and manage the QMS process from R&D through operationsResponsible for Customer Facing HCQM contact, ensuring Customer needs are met.Key contact for customer audits, document requests and routine communicationsManage 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 manufacturingCustomer 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 metResponsible for KPI development and reporting for the QA Department and manages shelf-life monitoring and extensions for both raw materials and finished productsResponsible for document control, Pest Control, Management of Change, KPI reporting and follow-up and shelf-life monitoring and extensionsAll other duties as assignedDrive Quality in ExecutionEnhances accessibility and utilization of the Quality Monitoring Scheme (QMS) which documents the quality requirements for each product manufactured and ensure alignment to the MSPECAct 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 metPrepares for and represents organization as primary contact for all customer auditsResponsible for KPI development and reporting for the QA Department and manages shelf-life monitoring and extensions for both raw materials and finished productsResponsible for document control, Pest Control, Management of Change, KPI reporting, shelf-life monitoring and extensions Qualifications: Bachelors degree in Food Science, Food Engineering, Chemistry or related field required10+ years of experience in a cGMP environmentExperience with manufacturing of aseptic products and thermal processingKnowledge of system design and experience working with implementing robust sustainable programsEnjoys project work and wants to make a difference by implementing best-in-class quality and engineering systemsRecognizes process waste and leads others to drive improvementFamiliar with and use of Lean Six Sigma tools to drive improvements in systems and process Belt or Black Belt preferredIdentify stake-holders and communicate effectively both verbally and in writing to all levels of the organizationEnsure Quality by Design from ideation through commercializationManages the overarching quality system including the development, deployment and maintenance of Prerequisite Programs and associated SSOPsDevelop and implement Engineering systems to manage buildings and equipment, through their life-cycle including - adoption of new technologies, testing and validation of equipment, and obsolescenceParticipates in and provides input to design of products and processes Why is This a Great Opportunity: Excellent work culture, very high paced and one of the fastest growing organizations in their industry segment.

Keywords: Affinity Executive Search, Indianapolis , Quality Systems Manager, Executive , Indianapolis, Indiana