Summary :
The Quality Manager is responsible for developing, implementing, and maintaining quality systems and processes that ensure compliance with healthcare regulations and industry standards. The role focuses on maintaining high product and service quality within a HealthTech environment - including software-based medical solutions, digital health devices & while driving continuous improvement across operations, product development, Tech and clinical Quality Management System (QMS) :
- Establish, implement, and maintain ISO 9001-compliant Quality Management Systems.
- Develop and manage standard operating procedures (SOPs) across departments.
- Oversee internal and external quality audits.
- Ensure CAPA (Corrective and Preventive Action) processes are implemented effectively.
2. Regulatory Compliance :
Ensure compliance like HIPPA, GDPR and relevant HealthTech regulatory standards.3. Product & Software Quality Assurance :
Oversee quality assurance for digital health software (SaMD) and connected medical devices.Conduct quality checks during software development lifecycle - including validation, verification, and usability testing.5. Continuous Improvement :
Lead root-cause analysis and implement process improvements.Monitor KPIs and drive quality metrics across the organization.Promote a culture of continuous improvement through training and engagement.6. Key Skills and Competencies :
Strong knowledge of ISO 13485, ISO 9001, and others.Experience in handling external audits.Excellent analytical and problem-solving skills.Strong communication and leadership skills for cross-functional collaboration.Experience with QMS software.Desired Candidate Profile :
Bachelor's or master's degree in pharmacy, Life Sciences, Engineering, or related field.5+ years of experience in Quality Assurance and / or Regulatory Affairs in the pharmaceutical, Health-tech industry. Strong understanding of ISO standards, and regulatory guidelines.Excellent communication, leadership, and organizational skillsKnowledge of data privacy and cybersecurity standards (GDPR, HIPAA) is an advantage.(ref : iimjobs.com)