The Quality Coordinator is a member of the Quality team. The primary responsibilities of this position are to maintain the Quality Management System documentation, coordinate the Complaint Processing and internal audit systems, and support the Quality department in meeting company objectives. This position reports to the VP of Quality & Operations and is a full-time, exempt positive located in our Ann Arbor, MI office.
Document Control (40%)
- Administer and maintain the Quality System document control process including:
- Track and maintain all SOP, WI and F in hard and soft copies, previous and current revisions
- Maintain Document Control Order (DCO) and Engineering Change Notification (ECN) logs
- Store, maintain and control access to original hard copy Quality System documents
Complaint Processing (40%)
- Receive complaints from Customer Service department
- Log complaints into tracking system
- Create complaint file, including completing a prioritization sheet for each complaint
- Assign complaints to investigators
- Prepare and submit applicable abbreviated complaints for approval and closure
Maintain Complaint Tracking System (20%)
- Maintain the complaint data tracking spreadsheet
- Process complaints approved for closure including verifying all required documentation is present and complete
- Log closure data into tracking system
- Generate and distribute routine and requested complaint reports
- Set up and lead complaint system meetings, e.g. Complaint Core Team meeting and Unresolved Complaints meeting
- Complete weekly and monthly graphs as required and tracking and trending reports as needed
Other related activity as assigned
- Assist the Director of Quality and Regulatory/Management Representative in preparing notifications to FDA and other regulatory bodies
- Identify, lead/assist and execute continuous improvement projects
Qualifications / Requirements
The qualifications listed below are representative of the knowledge, skill, and/or ability required.
- Previous FDA complaint handling experience in the medical device industry preferred but not required.
- Strong administrative and customer service background.
- Microsoft Office knowledge required.
- Strong documentation skills.
Education & Experience
- Bachelor’s degree preferred or demonstrated equivalent experience.
- Desired background in medical devices, computer science or information technology.
Xoran Technologies LLC. is an equal opportunity employer. All applicants for employment will receive consideration for employment without regard to race, color, religion, sex, national origin, qualifying disability, age, height, weight, marital status, veteran status, or any other protected classification under the law.