Quality Analyst

Job Title: Analyst, Quality

Location (On-site, Remote, or Hybrid?): Saint Paul, MN (onsite)

Contract Duration: Contract until 01/22/2027

Working hours: 8:00am - 5:00am

Total hours: 40

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 compliancerelated 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

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.

Education

Bachelor’s degree preferred in Biotechnology, Biology, Chemistry, Engineering, or a related scientific discipline.