Quality Systems Specialist I

Acist Medical Systems • Eden Prairie, MN

402d

About The Position

The Quality Systems Specialist I at Bracco Medical Technologies plays a crucial role in supporting the maintenance and enhancement of the Quality Management System. This position is responsible for ensuring compliance with relevant standards and regulations, facilitating audits, and managing documentation processes to uphold the quality of medical devices that empower lifesaving decisions.

Requirements

• Bachelor's degree plus 1-3 years experience, or a High School Diploma plus minimum of 5 years experience in Quality Assurance or Document Control role in a medical device manufacturing environment
• Medical device and/or pharmaceutical industry experience
• Beginning Knowledge of ISO 13485 and other Quality System regulations (e.g., FDA Quality System Regulation and EU MDD/MDR)
• Microsoft Office experience
• Strong interpersonal and communication skills
• Familiar with manufacturing shop order controls and engineering change orders
• Familiar with inventory MRP/ERP systems, such as SAP
• Good organizational skills
• Familiar with Good Documentation Practices (GDP)

Nice To Haves

• Medical Device Quality System experience in an FDA-regulated environment
• Experience administering engineering change orders for a Medical Device manufacturer

Responsibilities

• Initiate, facilitate and/or manage projects to expand, change, enhance, and improve the quality system, as assigned
• Create, review, and maintain quality system SOPs, work instructions, and other documents as assigned
• Support Notified Body audits, customer/partner audits, and FDA inspections
• Participate on project teams as assigned
• Process change orders to ensure timely and accurate completion, including updates to ERP system
• Ensure released documentation is appropriately filed and all documents sent to required external organizations and verified as received
• File, scan, and facilitate electronic storage of Device History Records, and/or compile, ship, and review records sent to third-party for storage
• Provide training, guidance, and customer support to Documentation System users
• Administer the learning management system by assigning training in the Learning Management System (LMS)
• Enter employee training requirements in the LMS
• Create online courses in the LMS
• Assign required employees to take online courses in the LMS
• Run reports as required from the LMS and audit for accuracy

What This Job Offers

• Job Type: Full-time
• Industry: Miscellaneous Manufacturing
• Education Level: High school or GED