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).

• 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.

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.

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