QA MANAGER jobs at chennai Ambattur location 2025

QA MANAGER jobs at chennai Ambattur location 2025

Full job description

Key responsibilities

Quality Management System (QMS): Develop, implement, and maintain an ISO 13485-compliant
QMS, including documentation, procedures, and policies. Stay current with regulatory requirements
and industry best practices.
Audits: Lead and manage internal and external quality audits, and support the team during audits by
providing necessary records and documentation.
Risk Management: Conduct risk assessments, develop risk mitigation strategies, and participate in risk
management activities throughout the product lifecycle.
Compliance and Documentation: Ensure all quality-related activities and documentation (e.g.,
process descriptions, test plans, change controls, deviations) comply with regulations and internal
standards. Review and approve quality records.
Problem Solving and Improvement: Investigate non-conformities, identify root causes, and
implement corrective and preventive actions (CAPA). Drive continuous improvement initiatives to
enhance product quality and process efficiency.

Team and Project Management: Lead and manage the QA team, provide input and support to cross-
functional teams, and oversee product testing efforts.

Product Lifecycle Support: Provide QA support throughout the design, development, and
manufacturing phases to ensure product quality and safety meet specifications and regulatory
requirements.

Qualifications

Bachelors or master's degree in a relevant field like life sciences or engineering.
Experience with medical device regulations (e.g., EU MDR, FDA) and quality management systems
(ISO 13485).
Strong understanding of quality assurance processes, including CAPA, complaint handling, and internal
auditing.
Experience in risk management.
Excellent analytical, problem-solving, and communication skills.
Experience in managing a QA team.

Regards,
Nedhra -HR
89251 and 14937

All the best