Quality Engineer

The Quality Engineer will support and maintain the Quality Management System (QMS) in a regulated medical device environment. This role is responsible for activities including document control, regulatory compliance, sterilization coordination, CAPA, risk management, and audit support related to the design, development, manufacture, and distribution of medical devices.

• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and applicable international medical device regulations (including MDR)
• Support and maintain compliance with QSR and GMP requirements across assigned areas
• Manage the Corrective and Preventive Action (CAPA) process from investigation through effectiveness checks
• Maintain Design History Files (DHF), Technical Files, and supporting documentation for internal and external audits
• Coordinate and support sterilization qualifications and ongoing maintenance activities
• Review and approve validation protocols and reports (IQ/OQ/PQ)
• Utilize quality tools such as FMEA, Control Plans, and Process Flow Diagrams
• Support risk management activities throughout the product lifecycle
• Develop, execute, and document department and company-wide training
• Organize and prioritize multiple tasks to meet project timelines and business needs
• Prepare and review technical documentation with a high level of accuracy and clarity

• Bachelor’s Degree in Engineering or a related technical field

• Minimum of 5 years of quality engineering experience in an ISO-regulated and/or medical device environment

• Strong working knowledge of verification and validation processes
• Proficient in Microsoft Office (Word, Excel, Outlook)
• Excellent verbal and written communication skills in English
• Strong technical writing and documentation skills
• Experience with risk management methodologies preferred

• Ability to sit or stand for extended periods
• Ability to work at a computer for normal business durations
  
  Office and manufacturing environment
• Regular interaction with cross‑functional teams