Executive-QA/RA

Job Title : Executive-Quality Assurance/Regularly Affair

Position Type: Regular

Department: Quality Assurance/Regularly Affair - CL

Location: Mohali

Number of Posts: 1

Industry Type: Medical Device Manufacturing

Qualification & Experience:

1. Degree/Diploma in electronics with 2-4 years of experience in manufacturing industry.
2. Should have hands on exposure to ERP system.
3. Should be able to train & manage team activities under this profile.

Job Responsibilities :

1. Prepare the Quality Management System Documents (Quality Manual, SOP, WI and Formats as applicable) as per applicable standard.
2. Define Quality objectives for function and roles in consultation with top management.
3. Ensure awareness of quality policy throughout the organization by suitable means.
4. Implement QMS Documents for each process/function.
5. Ensure that all documents are legible and signed by appropriate person.
6. Reporting to top Management on the effectiveness of the quality management system and any need for improvement.
7. Prepare and maintain master list of documents.
8. Change /Modify documents on request through DCN (Documents Change Note).
9. Ensure that changed/modified document is reviewed and approved by same role as original documents.
10. Ensure that all circulated documents are controlled copy of master documents.
11. Ensure the promotion of awareness of applicable regulatory requirements and quality management.
12. Conduct internal audits as per QMS and ensure corrective actions against all non-conformances. Also conduct surprised/unannounced audits to check effective working QMS.
13. Identify training needs in consultation with respective HOD s and coordinate trainings as required.
14. Plan and conduct the MRM at defined intervals after internal audit.
15. Follow-up with certification bodies for initial/surveillance audits.
16. Provide and implement corrective actions against non-conformances reported in external audits.
17. Keep updated on latest revision of applicable standards and align documents accordingly.
18. Monitor quality objectives of roles and functions, and discussed with top management for action.
19. Ensure compliance with Quality Management System (QMS) requirements and regulatory standards applicable to medical devices/any other product categories, including maintaining accurate detailed documentation, and records related to compliance activities
20. Any other responsibility assigned from time to time by Management.

Key Skills:

1. Should be Result oriented to achieve set targets
2. Should have Good communication skills
3. Should be disciplined and Punctual.