Qa sr. Executive

Career Ahead; Dadri; On-site; INR 600,000 - 900,000; Full time

Job summary

Career Ahead, Noida, is hiring a Sr. Executive QA to strengthen our quality assurance team. You will manage device and material master records, support audits, and ensure compliance with ISO 13485, MDSAP, and CFR standards.

Responsibilities include updating technical files, handling customer complaints, and maintaining QMS documentation. You will also coordinate calibration, training, and internal audit activities to sustain product quality across operations.

Qualifications

• 2–7 years of QA experience.
• Knowledge of ISO 13485 / MDSAP and 21 CFR 820 is preferred.
• Strong documentation and regulatory compliance skills.
• Ability to update technical and master records accurately.
• Experience in calibration management.

Responsibilities

• Update Device Master Records (DMRs) as per customer.
• Update RMMS: raw material master specs in Quality System.
• Assist in updating Technical files as required.
• Handle customer complaint documentation from receipt to closure.
• Maintain Quality Management System documents per ISO 13485 / MDSAP / CFR.
• Prepare six monthly MRM documentation and records.
• Compile machine manuals, SOPs, WIs and related docs.
• Assist in closure of NC and CAPA from audits.
• Support shop floor QA activities for new products.
• Document internal audits and maintain records.
• Conduct shop floor quality training and logs.
• Maintain external docs sent to customers.
• Ensure timely calibrations and calibration certificates with QC.
• Assist in Design Dossier preparation.

Skills

Quality Assurance

Documentation

Regulatory compliance

Audit support

GxP knowledge

Job description

Dear candidate,

We are hiring Sr. executive QA.

Experience: 2-7 years

CTC: hike on current salary

Location: Noida

Functional Responsibilities

• Updating Device Master Records (DMRs) as per customer.
• Updating RMMS (raw material master specifications as and when introduced into the Quality System.
• Assist in updation of Technical files as per requirements.
• Handling Customer Complaint documentation; receipt till closure and maintaining complaint log.
• Maintaining Quality Management System documentation as per standard / guideline requirements. (E.g. ISO 13485 /MDSAP, 21 CFR 820, EU/745 2017 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.

Thanks Regards