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Quality System Coordinator

Employer
Ware Technology Services
Location
Plymouth, MN
Start date
Aug 2, 2019
Closing date
Sep 1, 2019

View more

Category
Healthcare
Job Type
Employee
Employment Status
Full Time

Job Details

Ware Technology Services is partnering with a local company to fill a Quality Systems Coordinator! 
The Quality Systems Coordinator position will provide support in the collection, monitoring, and distribution of quality system documented information to facilitate the effectiveness, efficiency, and continuous improvement of the quality system, including compliance to external standards, customer requirements, and internal policies through a combination of administration, coordination, guidance, enforcement, and direct participation of/in quality system processes.
Manage retention of records required to demonstrate quality system conformance.
Evaluate and assure documents and records conform to established Good Documentation Practices and Document Control compliance.
Review documents for completeness and accuracy; ensure compliance with established processes and standards.
Generate Certificates of Conformance for customer shipments.
Provide support regarding Label Management (labeling creation, distribution, troubleshooting support for third parties and company sites, etc.).
Support the Training Management System for Quality, managing training records, and coordinating training of third parties and company sites.
Support in compilation and analyzing process metrics for Key Performance Indicators (KPIs) through the creation and maintenance of logs/registers, spreadsheets, databases, or other IT applications.
Support and guide the Process Deviation Request process.
Monitor status of action plans arising from processes including internal audit, CAPA, Management Review, Deviations, and Change Management.
Monitor the calibration management system to ensure timely re-calibration of measuring equipment.
Develop and maintain databases, logs, and/or other tools for effective management of required records and information.

Associate’s degree, technical school certificate/diploma, or equivalent experience.
2+ years’ experience in quality systems coordination, preferably in an ISO 9001 certified and/or life-science regulated environment (pharmaceutical, biologics, or medical device).
Knowledge of one or more Document Control, CAPA, Audit, Nonconforming Product, Inspection, or other quality system practices required.
Experience working with Electronic Document Management, Product Data Management (PDM), Product Lifecycle Management (PLM), or Enterprise Resource Planning (ERP) systems is highly desired.
Must be familiar with engineering and manufacturing documentation, and bills of material (BOM’s).


Company

Engineering & IT

As in any profession, the key to success is knowing what your strengths are and then finding the opportunity to use them. Ware Technology Services allows you to utilize and develop your skills through exciting projects with great companies in your area. And, because we take care of all the work involved in finding the right opportunities, you can focus on advancing your career.

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