Quality Assurance Specialist
Express Diagnostics Int'l, Inc. - Blue Earth, MN

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Quality Assurance Specialist
The Express Diagnostics Quality Assurance Specialist provides technical, quantitative, and coordination support to assure products and processes are designed, deployed, and operated according to requirements. Work-scope of this position includes support for the Design Control and Risk Management process. Additionally, this individual will ensure consistent implementation, improvement and compliance to the Express Diagnostics Quality System and global regulations including, but not limited to: FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR) ISO 13485 and In-Vitro Diagnostics Directive (IVDD). The Quality Assurance Specialist is a team player participating in design project teams to facilitate collaboration in the design control and risk management processes.

Reports to: Quality Systems and Regulatory Affairs Supervisor

Basic Tasks:

  • Generate quality assurance reports and analyze trending
  • Communicate report findings and analysis to supervisors
  • Facilitate product and process documentation
  • Research, acquire and ensure timeliness of documents of external origin, including but not limited to customer/vendor related documents and ISO standards
  • Assist in maintaining and ensuring data integrity in the quality assurance system including the following modules: change control, material mast, bill of material and routings
  • Prepare document/engineering changes for approval including the following: error checking, engineering change log files, document scanning
  • Evaluate master documents to meet the requirements of approved engineering changes
  • Assist in ensuring integrity of device master records and technical files
  • Support quality department management by investigating CAPAs, managing CAPA processes and ensuring timely and effective closure of actions
  • Perform and/or support internal quality audits

Requirements:

  • Proven experience providing quality support to project teams in the areas of design controls and risk management
  • Complete understanding and good practice of quality systems from design control to release of finished product in accordance with FDA Quality System Regulation (QSR), Canadian Medical Device Regulatory (CMDR) ISO 13485 and In-Vitro Diagnostics Directive (IVDD)
  • Proven ability to perform process flow and risk assessment
  • Proven experience with in vitro diagnostic requirements culminating in a successful 510(k) clearance
  • Proven ability to technically review all design documentation for acceptability prior to transfer to manufacturing
  • Working knowledge of statistical techniques
  • Proven ability to create document plans, test procedures, bills of material, which are required for successful transition of product design to manufacturing and operations
  • As part of the design control team, train personnel in quality requirements
  • Experience with non-conforming materials, returned product and service
  • A working knowledge of the elements of lean manufacturing and workflow analysis
  • Demonstrated successful ability to investigate, evaluate and support CAPA and complaint investigations
  • Ability to work well on fast-paced technical teams, at times taking a leadership role as needed
  • Demonstrated initiative and ability to work with minimal supervision

Education or Skills Requirements

  • BS degree in a technical field, master’s degree preferred
  • ASQ certified, CQE preferred
  • Quality assurance with experience in a technical environment
  • Knowledge in ISO 9001:2000 and ISO 13485:2003 are highly desirable
  • Experience in internal quality auditing desirable
  • Proficiency in collaborative workflow systems
  • Proficiency in MS Excel, MS Word, MS PowerPoint, and Access Database
  • Experience with MRP/ERP systems desirable
  • Excellent written and oral communication skills
  • Excellent organizational skills and attention to detail

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About this company
We’ve been proud to call Blue Earth, Minn., home since beginning operations in 2004. We attribute much of our growth to the great work...