Description
Responsibilities:The quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820 and ISO13485 (and other regulations as applicable) and for providing data regarding the performance of the quality system that will be presented to management with executive responsibility for review.
This role utilizes extensive internal and external partnering skills and must be knowledgeable with other cross-functional disciplines and processes such as R&D, Regulatory, Clinical and Manufacturing.
Knowledge of:
CAPA support
Post Market Surveillance
Configuration Management
Risk Management
Validation protocals
Compliance
Design Assurance
Lead auditor certification
Experience:
- 2-5 years of medical device quality assurance experience, preferably in quality compliance supporting CAPA, validation activities, Post Market Surveillance, data analysis and continuous improvement.
- Must be knowledgeable in Quality System Regulations, Medical Device Directive, ISO14971, ISO10993 series, TIR12, TIR 30, ISO11135 series, IEC60601 series, and ISO13485 Quality Standards.
- Strong background in statistical techniques, root cause analysis tools
- QSR/ISO auditing experience