Quality Systems Manager

2 weeks ago

Indianapolis, United States Stealth Recruiting Services Full time
Job DescriptionJob Description

100k to 140k

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 Heartland 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
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

 

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 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

Why is This a Great Opportunity

Excellent work culture, very high paced and one of the fastest growing organizations in their industry segment.

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