Job Openings

Quality Systems Manager

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Location
Indiana5polis, IN
Salary
$55,000 - $75,000
Job Type
Direct Hire
Degree
Associate of Science
Date
Jul 11, 2017
Job ID
2500794
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Description
 
The Quality Systems Manager is responsible for planning and executing all internal auditing to ensure compliance to ISO and NP requirements. Included within this activity are the management of the CAPA process, internal auditing, site document control processes and the coordination of all customer complaint investigation reports.
 
The Quality Systems Manager has responsibility for overseeing, leading, and improving the overall efficiency, effectiveness, productivity, and quality for identified value streams and support departments (business processes) using Lean, Six Sigma and project management tools. Position is responsible for identifying and implementing continuous improvement initiatives for processes, equipment functionality, costing, waste, and productivity. This position is also responsible for analyzing production and transactional processes to identify the cause of problems using problem-solving methodologies, and then working to create and implement solutions. In order to sustain continuous improvement efforts many of the control actions need to be incorporated into our Quality System.
 
The incumbent will act as the lead ISO auditor in the facility, providing training and direction to various internal organizations regarding auditing and compliance.
 
EDUCATION/CERTIFICATION:
 
AA or equivalent job experience. ASQ certification preferred. Lean Certification, Black Belt Certification preferred or Green Belt.
 
Proficiency in Microsoft platforms including but not limited to Word, Excel, Visio, Minitab or other suitable statistical software with the ability to organize, interpret, and present data.
 
Robust understanding of cGMP’s and ISO 9001/2000.
 
Root Cause Analysis background preferred
 
Understanding of Design Control systems, preferred.
 
EXPERIENCE REQUIRED:
 
Coordination of Document control systems.
 
Supervisory skill sets preferred in order to coordinate temporary external resources.
 
Experience in a high speed manufacturing environment a plus.
 
Working in a cGMP facility (FDA regulated), food packaging or nonwoven converting operation is highly desirable.
 
SKILLS/ABILITIES:
 
Strong leadership skills.
 
Strong communication and presentation skills.
 
Strong Computer and Information Technology skills.
 
Excellent verbal and written communication skills demonstrated by the ability to generate reports.
 
Able to multi-task and coordinate project based activities.
 
Strong math skills with the ability to utilize SPC and other statistical tools
 
Willing to work overtime and varied shift assignments as required
 
Knowledge of cGMP’s and other FDA-related regulations