Job details
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.
