Quality Assurance - Assistant Manager / Senior Executive

Devg Services

3 - 8 years

3 - 7 Lacs

manesar

Posted:-1 days ago| Platform:

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Skills Required

capa qms iso documentation quality assurance quality documentation quality audit quality system implementation iso audit qa systems qms implementation system audit quality procedures

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

Lead the implementation, maintenance, and enhancement of the Quality Management System as per ISO 13485:2016 and relevant international standards.
Manage and oversee the Corrective and Preventive Action (CAPA) system, ensuring timely investigation, root cause analysis, and closure.
Plan, schedule, and conduct internal audits across departments; coordinate and support external audits by customers, certification bodies, or regulatory authorities.
Evaluate and resolve non-conformances (NCs), manage deviation records, and ensure corrective measures are implemented effectively.
Collaborate with cross-functional teams to drive quality improvements and process compliance across the organization.
Review and update quality documentation, SOPs, audit trails, and training records.
Conduct training and awareness programs on QMS, CAPA, deviation handling, and audit readiness.
Ensure regulatory preparedness and support documentation for submissions and inspections
Manage the validation plan through out the organization.

Qualifications & Experience:

Bachelors / Master’s degree in Pharmacy, Biotechnology
Minimum 5–8 years of relevant experience in QA/QMS roles within medical device, pharmaceutical.
Strong understanding and hands-on experience with ISO 13485:2016, QMS, CAPA, audits, and regulatory documentation.
Prior experience in handling customer audits and regulatory inspections is a must.
Excellent written and verbal communication skills.
Proficient in MS Office and electronic QMS tools (preferred).

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