Quality Systems Specialist

About This Role

Ensure the successful implementation of ISO 13485 certified quality management system policies and procedures for medical devices. Uphold quality processes and ensure products meet quality standards and customer requirements.

Responsibilities

• Ensure quality procedures are being followed to ensure quality and revise documentation as necessary
• Assure calibration program is current and maintained; schedule equipment maintenance, cleaning, and calibration
• Review, coordinate, and close customer feedback (complaints, warranty, DOA's)
• Take appropriate corrective action in accordance with the CAPA process
• Ensure document control and change management processes are maintained
• Ensure all Washington Department of Health requirements are satisfied for use of x-ray equipment
• Manage radiation area monitors
• Collaborate with procurement to review and approve new vendors and evaluate current vendor performance
• Participate in internal and external audits
• Perform final QC inspections of all products and participate in quality awareness training for personnel
• Monitor production methods, product safety/quality, risk management, and customer feedback trends

Requirements

• 2+ years of experience with a quality management system
• Knowledge and familiarity with ISO 13485 and/or ISO 9001
• Good communication and project management skills
• Attention to detail and great organizational skills

Qualifications

• Bachelor’s degree in relevant field or an equivalent combination of skills, training, and experience
• 2+ years of experience with a quality management system

Skills

* Required skills