Regulatory Affairs and Quality Assurance Associate (Medical Device)

Des Moines, IA - USA

Monthly Salary: Not Disclosed

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Roles & Responsibilities

1. Implementation and continuous improvement of the Medical Device Quality
2. Management Systems and associated CE requirements in order to meet customer
3. and regulatory requirements
4. 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
6. Review and formal approval of technical reports.
7. Facilitate internal/external audits and evaluate audit findings and implement
8. appropriate corrective actions
9. Investigate customer complaints and non-conformance issues
10. Analyse data to identify areas for improvement in the quality system
11. Identify training needs and organize training interventions to meet quality standards
12. Monitor risk management activities
13. Responsible for document management systems
14. Managing the Inventory & Batch Verifications
15. Management Representative: responsibilities shall be -
a. ensuring that processes needed for the quality management system are documented;
b. reporting to top management on the effectiveness of the quality management system and any need for improvement;
c. ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

Experience/Knowledge/Technical Skills Required:

1. Around 2 to 5 years of experience in implementation in the QA domain preferably with some experience in working in the Medical Devices industry
2. Internal/Lead Auditor of Quality Management Systems
3. Knowledge and application skills of QC/Problem solving tools
4. Good computer skills
5. Knowledge of relevant regulatory/CE requirements for medical devices will be preferred 6. Analytical and structured working style attention to details
7. Ability to work as part of a team
8. Good verbal and written communication skills

Roles & Responsibilities1. Implementation and continuous improvement of the Medical Device Quality2. Management Systems and associated CE requirements in order to meet customer3. and regulatory requirements 4. Preparation implementation and Maintenance of Manual policies work instructions as per ISO...