Found Description
Job Description
- Understand CW ISO 13485 quality system, be responsible in developing and implementing quality system and control for ISO 13485 and ISO 9001
- Ensures organizational activities comply with established quality policy, procedures, and applicable international/national medical device regulations and standards
- Management Reviews Meeting
- Conduct management review meeting every 6 months and/or as required
- Discuss findings
- Document management review meeting
- Test instrument calibration
- Send instruments for yearly calibration and/or as required
- Maintain test instrument calibration procedures and maintenance schedules
- Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities
- Nonconforming incoming materials
- Liaise with procurement and supplier