Analyst, Quality

Quality Analyst
$35 hourly
St Paul, MN
Onsite 

This position is for a Quality Analyst-Regulatory Compliance Specialist.
This position will provide support to the Regulatory Compliance team and will assist with regulatory compliance activities.
Under the direction of department management, this role performs a variety of tasks related to Regulatory Compliance and the Quality Management System (QMS).

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, detailoriented work practices.
-Assist in the development and execution of streamlined business systems to effectively identify and resolve quality issues.
-Apply sound, systematic problemsolving 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
2-5 years of quality and/or regulatory experience, or
2 years of relevant industrial experience, typically within quality, product development/support, or scientific affairs functions.

Top Skills
Working knowledge of regulations and standards affecting medical devices.
Strong attention to detail and organizational skills.
Ability to learn new systems and processes efficiently.