Quality Management Systems Specialist

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

Apr 15, 2025 - 18:46

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