Quality Assurance

Dear candidate,

QA sr. executive.

Total Experience: 2+ years

CTC: as per industry standards

Location: Noida

Functional Responsibilities

Documentation & Regulatory Compliance

• Device Master Records (DMRs)

• Raw Material Master Specifications (RMMS)

• Technical Files

• ISO 13485, 21 CFR 820, EU MDR, CIS MoH requirements

• Management Review Meetings (MRM)

• SOPs

• Design Dossier

Audit, CAPA & Compliance Activities

• Non-Conformities (NCs)

• Internal Audits

• complaint log

Shop Floor & Training Activities

• Contribute to shop floor Quality Assurance activities for better understanding of existing and new products.

• Quality Training Calendar

Coordination & External Documentation

• Maintain external documentation, including documents sent to customers.

• Ensure timely calibration of instruments/equipment in coordination with Quality Control and compile calibration certificates.

Competencies

• Education:

• Experience:

• Quality Management Systems (QMS)

• MS Office

• Knowledge of regulatory requirements relevant to the medical device industry is an added advantage.

sadhna@careerahead.co.in

Thanks & Regards