Quality Engineer - Medical Devices and QMS Compliance

Quality Engineer

Work Flexibility: Hybrid or Onsite

What you will do:

• Independently manage and ensure compliance with the assigned QMS functions in line with of ISO 13485:2016 requirements.
• Management of Site Validation Program including execution and review of Validation activities of equipment, Processes, Test Method, facilities and utilities and computer system
• Handle Deviation, Risk Assessments, and Out of Calibration Results in accordance with established procedures.
• Review and monitor Preventive maintenance and AMC schedules ensuring timely execution and compliance.
• Coordinate and support Change Management activities
• Track, Analyze and report on Key Performance Indicators (KPIs) to ensure adherence to processes and prevent non-conformity relating to product, process or system.
• Perform data analysis using various statistical tools to support quality decision making.
• Work closely with cross-functional teams to ensure site compliance with QMS requirements.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.

What you will need:

Required

• Bachelor’s in engineering or science or Equivalent.
• 2-5 years of relevant experience in QMS or Quality Assurance. Experience in Medical Devices domain is an added advantage.
• Strong understanding of Quality Management Systems preferably ISO 13485 or ISO 9001
• Strong interpersonal skills, written, verbal communication skills. Basic analytical and problem-solving capabilities.
• Demonstrated ability to work in cross-functional team environments.
• Proficiency in Microsoft Office tools and Adobe Acrobat

Preferred

• Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)
• Ability to manage multiple tasks and represent the Quality function across teams. 

Travel Percentage: None

Experience Level

Mid Level