Quality Management Systems (QMS) Analyst

3M is science applied to life. At 3M, we are in your cell phone. We are in your car. We are at your doctor’s office. You are never more than 10 feet from a 3M product. 3M helps make it possible for many other companies to do what they do.

3M is seeking a Quality Management Systems (QMS) Analyst for the Health Care Business Group located in Maplewood, MN. Ready to be part of what’s next?

The person hired for the position of Quality Management Systems (QMS) Analyst will manage and support complaint handling workflow for one or more products within the 3M Health Care Business Group. Assure appropriate prioritization and timely closure of complaints. Assure compliance with all FDA regulations and internal procedures related to complaint handling.

• Manage complaint handling workflow
• Meet daily team and individual complaint handling output goals
• Perform complaint investigation to either close the complaint or determine need for more in-depth analysis
• Data entry and document retention needed for documentation of complaints
• Process complaint events as required per internal and FDA regulations/standards
• Monitors and tracks key operational data trending
• Work with cross-functional groups (Quality Engineers, Medical Complaint Investigators) when required

Basic Qualifications:

• Associate’s degree or higher from an accredited university
• Experience processing/analyzing complaints within the medical device, drug product, clinical research and/or clinical care environment (an internship is considered qualifying)

Preferred Qualifications:

• Bachelor’s degree or higher in Nursing, Science or related disciplines from an accredited university
• Knowledge of 21 Code of Federal Regulations (CFR) Part 820, Quality System Regulations
• Demonstrated oral and written communication skills
• Self-directed and comfortable with a transactional goal structured position
• Highly attentive to detail
• Microsoft Office proficient, related Complaint Processing SW a plus