Quality Analyst

The Fountain Group is currently seeking a Quality Analyst for a prominent client of ours. This position is located in ­­Saint Paul, MN. Details for the position are as follows:

Quality Analyst
Pay Range: $35-$41/hr depending on experience
Contract: 6-months with possible extension and/or conversion

Essential Functions
-Ensure Regulatory Compliance records are accurate, complete, and maintained in accordance with applicable requirements.
-Prepare, review, and maintain quality system and regulatory compliance documentation and records.
-Maintain and update compliance-related database records.
-Support QMS document control processes.
-Assist with the creation, maintenance, and updating of training materials and training audiences.
-Identify discrepancies between metadata fields and approval records.
-Update required fields in Windchill to ensure alignment with approval records.
-Learn and effectively navigate electronic systems used to manage records and data.
-Demonstrate initiative to ensure work is completed accurately and thoroughly.
-Maintain organized, detail oriented work practices.
-Assist in the development and execution of streamlined business systems to effectively identify and resolve quality issues.
-Apply sound, systematic problem solving methodologies to identify, prioritize, communicate, and resolve quality issues.
-Support company initiatives as directed by management and in alignment with the Quality --Management System (QMS).
-Comply with U.S. Food and Drug Administration (FDA) regulations, other applicable regulatory requirements, company policies, operating procedures, processes, and task assignments.
-Maintain positive, professional communication and collaboration with employees, customers, contractors, and vendors at all levels.
-Perform other related duties and responsibilities as assigned.

Experience

Required:


Bachelor's degree with medical device industry Quality Systems or Regulatory Compliance exposure - QMS / Document Control (regulated environment is required.
Experience maintaining quality records, regulatory documents, and compliance within FDA / ISO environments is required.
Systems experience (Windchill or similar PLM/eQMS) – Hands-on updating records, metadata, version control, and approvals in quality systems is highly preferred.
Must have proven experience ensuring audit readiness, reconciling discrepancies, and maintaining accurate, compliant documentation.
If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at .

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