Quality Engineer

Manpowergroup Services India

2 - 6 years

4 - 6 Lacs

faridabad

Posted:2 hours ago| Platform:

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Skills Required

capa management iso iso audit qms documentation risk management

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Maintain and enhance the Quality Management System (QMS) as per ISO 13485 and ISO 9001 requirements.

Prepare, update, and control QMS documents including SOPs, Work Instructions, Forms, Manuals, and Records.
Plan, execute, and report internal audits; track audit findings and ensure timely closure of corrective actions.
Support external audits conducted by notified bodies, customers, and regulatory authorities.
Lead CAPA processes including root cause analysis, corrective action planning, verification of effectiveness, and documentation.
Coordinate and maintain Risk Management files in alignment with ISO 14971.
Manage and monitor change control processes, ensuring evaluation, approval, and implementation of changes.
Ensure timely reporting and documentation of deviations, nonconformities, SCARs, and improvement actions.
Train employees on QMS procedures, compliance requirements, and documentation practices.
Review device history records (DHR), batch records, and QMS compliance during manufacturing.
Drive continuous improvement initiatives to strengthen compliance, efficiency, and documentation accuracy.
Support process validation, equipment qualification, and regulatory submissions by providing QMS documentation.

Preferred candidate profile

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