Quality Management Systems Specialist

Job Summary

A company is looking for a Quality Management Systems Specialist.

Key Responsibilities

• Act as a leader for the Medical Devices QMS team, drafting SOPs and technical documents
• Establish processes for medical device product development programs in compliance with FDA and ISO requirements
• Collaborate with engineering and product development teams to define standard operating procedures for design and risk management

Required Qualifications

• Bachelor's degree in a Technical Science; Master's preferred in quality assurance or equivalent
• 10+ years of experience in a regulated industry such as Medical Devices or Pharma
• Experience with ISO 13485, ISO 14971, 21 CFR 820, and other relevant regulations
• Experience in authoring technical reports and standard operating procedures
• Proven experience in regulatory compliance for medical devices