Job Purpose:

Assist in maintaining and improving company’s quality system.

Functional Responsibilities:

• Updating Device Master Records (DMRs) as per customer and registration requirements.
• Updating RMMS (raw material master specifications as and when introduced into the Quality System.
• Assist in updation of Technical files as per requirements.
• Maintaining Quality Management System documentation as per standard / guideline requirements. (E.g. ISO 13485, 21 CFR 820, EU or MoH of CIS countries).
• Assisting in organizing & documenting six monthly MRM and maintaining all documents as per requirements.
• Preparation and compilation of machine manuals, SOPs, WIs & Quality formats related documentation.
• Assisting in closure of NC and CAPA raised from external / internal audits
• Contribute in shop floor QA related activities for understanding of existing & new products
• Assist in documentation related to internal audits in the company.
• Conducting shop floor training as per Quality training calendar and maintaining records.
• Maintenance of external documentation such as documents sent to customers
• Ensuring timely calibrations of instruments/ equipment and compilation of calibration certificates in close coordination with Quality Control.
• Assisting in Design Dossier preparation.
• Complaint handling and maintaining complaint log.

Competencies

• B.Tech/B. Pharma/M. Pharma with 3-5yrs of experience in Quality Assurance.
• Knowledge of Quality Management Systems.
• Fair communication skills and computers skills, able to work with basic MS office
• Experience in Medical device Industry will be a bonus.
• Result orientation
• Working with and through others
• Customer centricity

Reporting to: AGM

Department: Quality Assurance

Position: Sr.Executive

Relevant Experience: 3 - 5 Years

Rev 04 Effective Date 09-09-2023 Page 1