What are the responsibilities and job description for the Regulatory Affairs and Quality Assurance Associate (Medical Device) position at Jobs via Dice?
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About The Job
Experience/Knowledge/Technical Skills Required:
About The Job
Experience/Knowledge/Technical Skills Required:
- Around 2 to 5 years of experience in implementation in the QA domain preferably with some experience in working in the Medical Devices industry
- Internal/Lead Auditor of Quality Management Systems
- Knowledge and application skills of QC/Problem solving tools
- Good computer skills
- Knowledge of relevant regulatory/CE requirements for medical devices will be preferred 6. Analytical and structured working style, attention to details
- Ability to work as part of a team
- Good verbal and written communication skills
- Implementation and continuous improvement of the Medical Device Quality
- Management Systems and associated CE requirements in order to meet customer
- and regulatory requirements
- Preparation, implementation, and Maintenance of Manual, policies, work instructions as per ISO 13485 5. Preparation, implementation, and Maintenance of Technical documentation (MDR) wrt applicable requirements
- Review and formal approval of technical reports.
- Facilitate internal/external audits and evaluate audit findings and implement
- appropriate corrective actions
- Investigate customer complaints and non-conformance issues
- Analyse data to identify areas for improvement in the quality system
- Identify training needs and organize training interventions to meet quality standards
- Monitor risk management activities
- Responsible for document management systems
- Managing the Inventory & Batch Verifications
- Management Representative: responsibilities shall be -
- ensuring that processes needed for the quality management system are documented;
- reporting to top management on the effectiveness of the quality management system and any need for improvement;
- ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.