Responsibilities:

• Help create, monitor, and improve ISO 13485 and 21 CFR 820 quality management system (QMS)
• Develop processes and write procedures to ensure regulatory requirements and business needs are efficiently and effectively met.
• Manage or assist in the management of the following systems:
  • • Corrective Action and Non-Conforming Materials
    • Training
    • Equipment validation, maintenance, and calibration
    • Complaints and Post-market Feedback
    • Internal and Supplier Audits

Requirements:

• 4-year technical degree
• 1-7 years’ experience in the medical device industry
• Knowledge of ISO 13485 and 21 CFR 820
• Experience with Product Lifecycle Management (PLM) or electronic Quality Management System (eQMS) preferred (Agile, Arena, MasterControl, Propel, etc.)
• Experience writing SOPs and work instructions
• Proficiency in Microsoft Office
• ASQ certification a plus