Suna Solutions ยท 16 hours ago
Quality System Contractor
Minnetonka, MN
Contract
Onsite
Mid Level
$25/hr - $28/hr
4+ years expSuna Solutions is seeking a Quality Systems Coordinator / Quality System Contractor to ensure regulatory compliance and the integrity of the Quality Management System. The role involves managing GxP records, administering quality event processes, and supporting complaint handling activities within the life sciences or medical device industry.
DeliveryHuman ResourcesInformation Technology
Hiring Manager
Rajesh Kumar
Responsibilities
Administer and monitor quality event processes, ensuring adherence to regulatory and company standards while tracking operational performance
Organize, sort, and maintain physical and electronic quality records in accordance with retention schedules and regulatory requirements
Ensure record accuracy, accessibility, and traceability across quality systems
Support complaint handling activities by accurately entering product complaint data into quality systems
Assist with the maintenance, control, and issuance of controlled logbooks
Provide support across multiple Quality System functions, including audits, CAPAs, document control, and training activities
Perform additional duties as needed to support departmental and organizational goals
Qualification
Required
High School Diploma or equivalent required
Minimum of 4 years of experience in the life sciences or medical device industry
Strong understanding of records management and regulatory compliance
Experience with MasterControl or similar Quality Management Systems
Working knowledge of GxP, 21 CFR, EU GMP, ICH, ISO, QSR, and related regulations
Familiarity with customer complaint handling processes
High level of integrity with a strong commitment to customer and patient safety
Excellent interpersonal and communication skills with the ability to collaborate across teams
Proactive, dependable, and eager to learn and take on additional responsibilities
Company
Suna Solutions
Suna Solutions is a staffing and recruiting company offering temporary staffing services.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase