Establish and support a work environment of continuous improvement that supports Quality Policy, Quality System, and the regulations. Strong familiarity with ISO 13485:2016 / MDSAP regulatory requirements is required.
- Maintain Site training compliance and provide Quality related trainings
- Plan, coordinate, and conduct scheduled internal audits to assess compliance with FDA, ISO, other applicable standard requirements, and internal requirements. To include audit scheduling, investigation, and evaluation of audit observation and findings.
- Drives changes in procedures and standards to facilitate work efficiency and to maintain quality
- Responsible for the implementation, co-ordination, and continuous review of the CAPA system as well as facilitation of CAPA management in other area of the organization
- Create and process change notices and perform additional tasks as needed for the support Production systems (MES, SAP)
Skills and Qualification
- Bachelor's degree in Life Science or equivalent
- Minimum of 5 years' experience in Quality Assurance or medical device field
- Experience in GMP and other Regulatory compliance requirements
- Self-confidence and the ability to work with all levels of organization
- Operates in a way that never compromises ethics and integrity
- Ability to understand and adapt to different cultures and market needs