Senior Quality Systems Specialist

Job Summary

A company is looking for a Senior Quality Systems Specialist.

Key Responsibilities

• Serve as quality team representative to cross-functional partners and drive design control activities for SaMD products
• Facilitate development and maintenance of product design documents and support risk management activities
• Lead quality system activities per ISO 13485, including complaint handling and supplier evaluations

Required Qualifications

• Minimum of 3 years of Quality Management experience in medical devices
• Knowledge of Quality Systems compliance with 21 CFR 820, ISO 13485, and other relevant regulations
• Experience with software development tools and Agile Software Development practices
• Previous experience in software as a medical device is preferred
• BA/BS degree in a technical field or equivalent practical experience