Quality Assurance Manager

13 hours ago

Ambattur Chennai Tamil Nadu, India GESCO Healthcare Pvt Ltd Full time ₹ 6,00,000 - ₹ 8,00,000 per year

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

Bachelor's 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

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.

Job Type: Full-time

Pay: ₹600, ₹800,000.00 per year

Benefits:

  • Food provided
  • Provident Fund

Application Question(s):

  • Notice period to join

Work Location: In person

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